SharePoint Configuration Guidance For 21 CFR Part 11 Compliance

SharePoint Configuration Guidance for 21 CFR Part 11 Compliance
Published: April 2012
Microsoft Corporation
Health and Life Sciences Industry Unit
Paragon Solutions
Health and Life Sciences Practice

Introduction ....................................................................................................................................................................................................1
Acknowledgements ........................................................................................................................................... 2
Architectural Approaches to Compliance ................................................................................................ 3
Use Cases for 21 CFR Part 11 Compliance ............................................................................................... 4

Electronic Signature Use Cases ..........................................................................................................................................................4
Digital Signatures Use Cases...............................................................................................................................................................6
Architecture for 21 CFR Part 11 Compliance .......................................................................................... 8

Windows Server 2008 R2 ......................................................................................................................................................................8
Active Directory Domain Services .....................................................................................................................................................8
Active Directory Rights Management Server ...............................................................................................................................8
Active Directory Certificate Services ................................................................................................................................................9
Active Directory Federation Services ............................................................................................................................................ 10
SQL Server 2008 R2.............................................................................................................................................................................. 10
SharePoint Designer ............................................................................................................................................................................ 10
SharePoint 2010 Architecture for Compliance ......................................................................................................................... 10
Database Security ................................................................................................................................................................................. 11
Configuring the Electronic Signature Use Cases ................................................................................ 12

Administrator Configuration for Single Signatures ................................................................................................................ 12
Digital Signatures Use Case ........................................................................................................................ 47

Administrator Configuration for Digital Signatures ............................................................................................................... 47
21 CFR Part 11 Requirements ..................................................................................................................... 56
Subpart B Electronic Records ..................................................................................................................... 57

11.10 Controls for Closed Systems ................................................................................................................................................ 57
11.30 Controls for Open Systems .................................................................................................................................................. 64
11.50 Signature Manifestations ...................................................................................................................................................... 65
11.70 Signature/Record Linking ..................................................................................................................................................... 65
Subpart C Electronic Signatures ................................................................................................................ 66

11.100 General Requirements ......................................................................................................................................................... 66
11.200 Electronic Signature Components and Controls ...................................................................................................... 67
11.300 Controls for Identification Codes/Passwords ............................................................................................................. 67
Systems Validation and Compliance ....................................................................................................... 70
SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

Introduction
Since the release of the Microsoft Office SharePoint Server 2007, compliance has
been a major focus of the Microsoft Office System. That focus continues with
SharePoint 2010 and includes additional functionality that further enhances
compliance capabilities.
In addition to the audit trails and document level security that were introduced in
SharePoint 2007, there are now enhanced capabilities for document and records
compliance. These enhanced features include:
 Records center document libraries can be placed anywhere in a site collection
 In-place records management in any document library
 Centrally managed and distributed content types and taxonomies
 Centrally managed policies and workflow enforced on content types
 Workflow can promote a document from loose collaboration to a formally
declared and managed record , including the capability for electronic
signatures.
 Multi-stage records disposition
Centralized audit trails and audit trail reporting that is easily configured with no
additional coding necessary.
While these features can be applied to a broad range of regulations, including
Sarbanes-Oxley and HIPAA, they also apply to 21 CFR Part 11. Thus the Microsoft
Office SharePoint Server 2010 when combined with other Microsoft technologies,
including Active Directory, Information Rights Management, and (optionally) the
Microsoft PKI system, provides a system that may be configured to assist with 21 CFR
Part 11 compliance.
In a departure from previous whitepapers on the topic, we approach this document a
bit of a different way:
1. Describe the overall SharePoint architecture needed to support compliance.
2. Including both conceptual and product-level architectures.
3. Provide a set of use cases for compliance and then detail the configurations
necessary to support those use cases.
4. Provide a mapping between 21 CFR Part 11 and the configurations detailed
as part of the use cases that support each individual line of the regulation.
This approach will be more useful for those involved in the validation effort as it
provides the use cases and then the configurations necessary for validation.
Of course, software cannot be compliant by itself, so SharePoint 2010 and other
Microsoft technologies must be used in conjunction with a broader compliance
framework, including appropriate configurations, policies, procedures and validation
documentation that are the responsibility of the implementing party.
1 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

Acknowledgements
As with any effort of this size, there are a myriad of persons involved in its development. In this case, the
efforts of Paragon Solutions (http://www.consultparagon.com) in the development of the demonstration
system, SharePoint configurations, workflows, SharePoint Designer configurations and sample source code,
all of which were absolutely essential for this project to be successful.
It is also necessary to acknowledge the Life Sciences Industry Unit members who wrote and reviewed the
configuration text, the use cases, regulation interpretation and guided the development of the end product.
Finally, it is necessary to acknowledge the efforts of the Microsoft Consulting Services on the 2007 version of
this whitepaper, portions of which remain intact especially in the section that maps each part of 21 CFR Part
11 to the needed configuration step.

Architectural Approaches to
Compliance
When considering regulatory compliance, whether it be for eDiscovery, Part 11, DDMAC, SOX, or any other
regulation, the most important step in the process is planning the architecture. While the SharePoint system
is eminently flexible, that flexibility can also pose challenges down the road if you take a wholly haphazard
approach. A good plan, consistently applied, will take you far and avoid pitfalls.
When building the plan it is important, first and foremost, to understand the overall capabilities of the
platform. In this case, it is important to understand that SharePoint has a plethora of capabilities in the
Enterprise Content Management (ECM) space.
Foundational ECM
Document Records Web Content Rich Media Document Human Centric E-Mail
Management Management Management Managment Output Workflow Archiving*
Supplemental ECM
Embrace and Extend Workloads with Partners
Transactional
Physical Records Business Process Scanning and Archiving and Industry Specific
Content
Management Management Capture Library Services Solutions
Management
Equally matched by the capabilities Foundational ECM capabilities in SharePoint are the plethora of partners
that embrace and extend the SharePoint platform. These include vendors that provide out-of-the-box Part
11 and GxP compliance, vendors that provide capabilities for scientists through electronic lab notebooks and
LIMS systems, even vendors that provide manufacturing and plant floor monitoring capabilities – all on
SharePoint. These are in addition to the workloads listed in the graphic above.
For the purposes of Part 11 compliance, we will be looking at the features that Microsoft categorizes as
Records Management . For planning Records Management systems, the implementer will need to factor in a
couple key considerations:
 Policies & Workflow

 File & Archival Plan – In-Place Records vs. Centrally Archived
 Managed Metadata and the Taxonomy Term Store
Managed Metadata and the Taxonomy Term Store provide more flexibility to the end user as well as the
system administrator when it comes to Metadata. Users are no longer simply consigned to setting the
metadata through dialog boxes at upload time, but can actually set the metadata for a document during the
authoring process. Similarly, content managers have the ability to manage the metadata, through
hierarchical means, and propagate those terms throughout a site collection.

The decision whether to use in-place records or centrally archived records becomes crucial when configuring
the system for Part 11 compliance. In this document, the workflows and configurations demonstrate both
approaches, by using in-place records for most electronic and digital signature workflows, but then using a
central archive record store once a document’s lifecycle has run its course.
Policies and workflow are central to configuring SharePoint 2010 for compliance with any regulation. In this
whitepaper we will discuss at length the use of workflow for electronic and digital signatures, as well as the
use of policies to determine which documents need signatures.
Given those key considerations, the balance of this document will be split into two parts:
1. A discussion of configuring SharePoint 2010 for Part 11 compliance
a. Utilize a Use Case methodology so the document can be used providing guidance for
your own validation efforts
b. Provide the architecture to support the Use Cases
c. Detail the workflow and policies for electronic signatures
d. Detail the workflow and policies for digital signatures
e. The promotion of records to in-place and centrally managed records

2. Mapping 21 CFR Part 11 to the areas of the previous use case to demonstrate how SharePoint
meets those regulations
Use Cases for 21 CFR Part 11

Compliance
In this section we will detail common use cases that require 21 CFR Part 11 compliance and then will step
through the configuration of the system for that use case.
There is another use case allowed for in Part 11, namely Biometric based signatures. While the combination
of Windows 7, Active Directory and hardware manufacturers provide for this capability which can be
extended to SharePoint, it is so uncommon a method of authentication and signature that it won’t be dealt
with in this context.
Electronic Signature Use Cases

The following use cases will detail the configurations and resulting process for applying an electronic
signature to a document either in a single signature scenario or in a multiple signature scenario.
Single Signature Use Case

To support the use case where the process requires a single electronic signature per document the site
administrator will:
 Configure document library templates for electronic signatures
o Update the document library with new columns
o Set the Content Approval Status

o Set the Document Version History settings
o Create and add document templates for embedded signatures (optional)

 Create workflows for Electronic Signatures
o Utilize SharePoint Designer
o Attach the workflow to the document library

 Set the policies for the document template
o Create custom security for the content-type
o Set permissions on the content-type so that regulated documents cannot have the version
history changed or versioned documents modified
 Create a customized page that captures the username and password for the electronic signature
o Twelve lines of source code (provided) are used to call the LDAP store to authenticate the
signature before storing it with the record.
o The source code for authentication is added to the SharePoint Designer page created for
the signature workflow.
Note: This system details use of an optional embedding of the signature into the Word Document, providing
a visible record in the document itself of the signature process.
The user will:

Navigate from the their project page to the document management library for that project
 View the documents currently in process and the workflow status of each document
 Author the document to make necessary changes
 Save the document to the library

 Submit the document for workflow approval
 Sign the document as part of the approval workflow
 View the audit trail (workflow history) of the document library
Multiple Signature Use Case

To support the use case where the process requires multiple electronic signatures per document the site
administrator will:
 Configure document library templates for electronic signatures
o Set the Document Version History settings which turns on audit trails.
o Create and add document templates for embedded signatures (optional)

 Create workflows for Electronic Signatures

history changed or versioned documents modified

 Create a customized page that captures the username and password for the electronic signature
o Twelve lines of source code (provided) are used to call the LDAP store to authenticate the
signature before storing it with the record.
o The source code for authentication is added to the SharePoint Designer page created for
the signature workflow.
Note: This system details use of an optional embedding of the signature into the Word Document, providing
a visible record in the document itself of the signature process.
Each signing user will:
 Navigate from the their project page to the document management library for that project

 Sign the document as part of the approval workflow
Digital Signatures Use Cases

The following use cases will detail the configurations and resulting process for applying a digital signature to
a document either in a single signature scenario or in a multiple signature scenario.
Single Signature Use Case

To support the use case where the process requires a single digital signature per document the site
administrator will:
 Configure document library templates for digital signatures
o Update the document library with appropriate columns for workflow

o Create and add document templates for digital signatures
 Create workflows for Digital Signatures

o Utilize SharePoint Designer (if designed)

history changed
These configurations will enable the user to:

 Sign the document in Office 2010 client

 Save the document to the document library as part of the workflow
Multiple Signature Use Case

To support the use case where the process requires a single digital signature per document the site
administrator will:
 Configure document library templates for digital signatures

o Create and add document templates for embedded signatures

 Create workflows for Digital Signatures

history changed
The user will:


 Sign the document in Office 2010 client
 Save the document to the library as part of the workflow
User Authentication Use Case

Security and access control are central concepts for compliance. With the new reality of cross-company
collaboration, authentication control is even more important.
However this is also more straightforward, as there are clear instructions in other Microsoft documents on
the use of Active Directory and Active Directory Federation Services with the use of SharePoint that a
discussion here is not necessary.

Architecture for 21 CFR Part 11
Compliance
Given the use cases detailed above, there are a few key architectural components that are required in order
to provide 21 CFR Part 11 compliance. As we detail each of these architectural components we will see how
Microsoft technologies, when used together can provide compliance with many different regulations, but
only as configured and implemented in the end-user's system and in the context of the implementers
requirements.
Windows Server 2008 R2

Windows Server is the basis for all the components needed for regulatory compliance. Some of the key
compliance features of Windows Server 2008 R2:
 The ability to provide detailed IQ reports when used with a software distribution system such as
Microsoft Systems Center Configuration Manager
 The ability to provide detailed OQ reports when used with the systems management provided
through Microsoft Systems Center Operations Manager.
 The ability to provide Network Access Protection which enforces health requirements by monitoring
and assessing the toll of client computers when they attempt to connect or communicate on a
network. Client computers that are not in compliance with the health policy can be provided
restricted network access until their configuration is updated and brought into compliance with
policy.
 The concept of server roles allows server administrators to quickly and easily configure any
Windows-based server to run a specific set of tasks and remove extraneous 0S code from system
overhead. Windows Server 2008 R2 further extends this model would support work more rules in a
broadening of current role support. The Server Core installation option is important to mention
here as it only includes necessary components for running applications such as SharePoint.
Active Directory Domain Services

Part of Windows Server 2008 R2 Core Infrastructure is Active Directory Domain Services. While SharePoint
can utilize an LDAP system, Active Directory provides the means to manage the identities and relationships
that make up your organization's network in a way that is easily integrated with the rest of your Microsoft-
based infrastructure. It gives out-of-the-box functionality needed to centrally configure and administer
system, user, and application settings.
Active Directory Rights Management Server

The next component in the identity and access management system is Active Directory Rights Management
Services (AD RMS). With AD RMS you can augment and organizations security strategy by protecting
information through a persistent usage policies, which remain with the information, no matter where it is
moved. You can use AD RMS to help prevent sensitive information such as clinical trial reports, site
monitoring documentation or even e-mails from intentionally or accidentally getting into the wrong hands.
In SharePoint 2010 this is configured through the Information Rights Management (IRM) screen which can
be applied at the document library or document library template level.

It is important to note that users do not have to have Office installed to read protected documents and
messages. SharePoint 2010 with Web Applications understands rights management, so any user with access
to a browser and rights to the document can view the document.
It is also important to note that users do not need to reside within your organization, as long as they are
granted appropriate rights. Any user with a Hotmail account or a LiveID can be granted access to a
document and then able to view it through a SkyDrive account or through e-mail.
Active Directory Certificate Services

Active Directory Certificate Services provides customizable services for issuing and managing certificates
used in software security systems employing public key technologies. Active directory certificate services cast
that allows organizations to deploy a digital certificate infrastructure, creating a Web of authentication
between devices, users, and applications.
AD CD is a role in Windows Server, which provides an integrated public key infrastructure (PKI) that enables
capabilities such as digital signatures, strong authentication, and secure communications.
These certificates when used in conjunction with Office 2010 provide the ability to sign Microsoft Office
documents which are compliant with the XML-DSign and XAdES standards for digital signatures. Since
XAdES forms the basis of other standards such as Safe BioPharma, this system can be integrated into a SAFE-
compliant system in a fairly straightforward manner.
What is XAdES?
XAdES (XML Advanced Electronic Signatures) is a set of tiered extensions to XML-DSig, the levels of which
build upon the previous to provide more and more reliable digital signatures.
By implementing XAdES, Office complies with the European Union Advanced Electronic Signature Criteria in
Directive 1999/93/EC as well as a new Brazilian government directive which defines XAdES as the accepted
standard for digital signing in Brazil.
Office 2010 can create different levels of XAdES signatures on top of XML-DSig signatures:

Time Stamping and XAdES-T Signatures
Time stamping digital signatures (XAdES-T signatures) is an important scenario we focused on in Office
2010. In order to create a time stamped signature, you’ll need to:
 Set up a timestamp server that complies with RFC 3161.

 Configure signature policy to let the client systems know where to locate the timestamp server.
You’ll also need to add the timestamp server’s root certificate to the root certificate store.
Once everything is configured, you can just create signatures like you normally would. A timestamp from a
trusted timestamp server extends the life of your signature, because even after the certificate expires, the
timestamp proves that the certificate had not expired at the time of signing. As a result, time stamping
protects against certificate expiration, and if the certificate was revoked after the signature was applied, the
signature is still valid.
Active Directory Federation Services

While not a hard and fast requirement for Part 11 compliance, ADFS provides simplified access and single
sign-on for on premises and cloud-based applications in the enterprise, across organizations, and on the
web. In the case of access to compliant SharePoint sites, it allows IT administrators and end users to grant
access to known entities, even users outside their organizational boundaries.
ADFS and SharePoint together accomplish this by using SAML 2.0 standard claims-based authentication and
security. Once the ADFS servers of two organizations are “pointed” at each other through a simple
configuration, end users from both organizations are free to collaborate, participate in workflow and even
execute electronic or digital signatures in both organizations SharePoint sites.
SQL Server 2008 R2

Microsoft SQL Server 2008 R2 is a complete set of enterprise ready technologies and tools that provide the
database and business intelligence technologies for SharePoint and many of the other Microsoft platforms.
As a database management platform, SQL Server 2008 R2 manages databases more efficiently and
effectively. It provides your people with built-in tools for greater control and oversight. It manages at scale,
automate automates tasks, and streamlines troubleshooting.
As the business intelligence platform, it is a comprehensive platform for business intelligence that includes
enhanced reporting, deeper and more powerful analysis, rich data modeling, master data management
capabilities, and full integration with Microsoft Office.
Microsoft SQL Server 2008 R2 also provides the database and business intelligence platform for SharePoint
2010. This “better together” capability means that not only does SQL Server store the objects and
configurations of SharePoint, but it also provides on-demand and self-service business intelligence, list
generation and PowerPivot capabilities.
SharePoint Designer
SharePoint Designer is the mechanism the IT Professionals and Power Users can use to create workflows,
design custom pages and other tasks that are not available in the SharePoint interface itself.
SharePoint 2010 Architecture for Compliance

When you bring all the pieces and parts together, you end up with a general architecture for compliance that
includes capabilities for workflow, electronic and digital signatures, document retention and archival and
audit trails or histories to prove that the signatures and documents are valid.

Windows Server 2008 R2
SQL Server 2008 R2

Active
Directory
Rights
Management
Services
SharePoint 2010
Certificate
Services
Electronic &
Document Records Digital
Policy Mgmt Workflow
Mgmt Mgmt Signature
Workflow
FAST
Enterprise
Search
While the overall architectural components are important, it is also key to identify proper organization, sizing
of the server farm, navigation and other concepts. Those elements are largely outside scope of this
document.
For information on the concepts of sizing, navigation and geographical disbursement, please visit
http://msdn.microsoft.com as well as http://www.microsoft.com/itshowcase for best practice information on
SharePoint implementation on an enterprise scale.
Database Security
21 CFR 11.10(d) notes that access to IT applications must be limited to authorized individuals. In addition to
internal safeguards built into a computerized system, external safeguards and policies should be put in place
to ensure that access to the computerized system and to the data is restricted to authorized personnel. Staff
should be kept thoroughly aware through training and procedures of system security measures and the
importance of limiting access to authorized personnel. Procedures and controls should be put in place to
prevent the altering, browsing, querying, or reporting of data via external software applications that do not
enter through the protective system software. IT guidelines, standard operating procedures and controls
typically ensure that access to back-end servers and applications is controlled.
There is a potential security issue where a person with elevated permissions to the WSS-Content-Database
could alter records in the database table and impact the Signed Person, Date signed, and Purpose of Signing
tables. Per typical IT operating measures, people with elevated permissions are typically authorized and
working under strict operating procedures. The likelihood of malicious changes is low. However, if someone
did alter the underlying database tables, SharePoint will not recognize these changes; hence the signature
would become invalidated.

If this is viewed as a security issue not handled well enough by internal IT operating procedures, there are
options. To fix this issue, an encryption key can be generated and stored in the document library. This key
would be used to determine if changes were made to the document properties using SQL update. A hash
key can be generated using the following columns from the document library:
 Signer Name
 Purpose of Signing
 DateTime (of signing)

 Version of the Document
 Document Status
A timer service can run to check approved documents to see if any changes were made in the WSS-Content-
Database. The encryption key is examined, and any changes noted will invalidate the document. If the
document is found to be invalid, a workflow will be invoked to send an email to the signer and/or an
administrator to note that the document has been changed by an unknown person and hence the
document is invalid.
There are other options for achieving this level of check and balance to ensure that a malicious activity at the
database level is discovered and accounted for. However, for most organizations internal IT operating
procedures preclude unauthorized access to servers and applications.
Configuring the Electronic

Signature Use Cases
Electronic signatures are a central component to 21 CFR Part 11 compliance. As specified in the use cases,
we’ll detail two mechanisms for electronic signatures: single signature documents and documents that
require multiple signatures.
In both use cases the configuration chosen makes a few key decisions:
 While not necessary, the electronically signed documents will contain a representation of the
signature that includes the name of the signing party, the date of the signature and the reason for
signing.
 Once signed, the document will be protected through Rights Management, so that the signed
version cannot be tampered with, but it may also be used to create another version.
 The electronic signature will remain in the document as well as in the audit trail/version history of
that document.
 Workflow can take the final electronically signed document and copy it to the records center for
final disposition and archival.
Administrator Configuration for Single Signatures

To support the use case where the process requires a single electronic signature per document the site
administrator will do the following tasks:

Configure document library templates
The first task is to select the document library to be enabled for electronic signatures.
Once in the target document library, click on the Library tab in the Ribbon Bar. This brings you to the
Document Library Settings page which enables you to add the necessary columns for electronic signatures.
To add columns in the document library click Library Tools > Library > Document Library Settings >
Create columns.

The following columns will be added:
 Username
 Purpose of Signature
 Document Status (needed for workflow processing)

 Date Signed
 Signers
To add columns in the document library click Library Tools > Library > Document Library Settings >
Create columns.

After adding the necessary columns, while still in the Document Library Settings, click on Versioning
Settings.

This brings you to Document Library > Document Library Settings > Versioning Settings screen which
enables you to control the versioning for the document library.
Under Require content approval for submitted documents, click Yes.
Click Create major versions, or other settings as needed by your company’s policies and procedures.
Configure Document Library Version Histories

After adding the necessary columns, while still in the Document Library Settings, click Versioning Settings.
This brings you to Document Library > Document Library Settings > Versioning Settings screen which
enables you to control the versioning for the document library.
Under Require content approval for submitted documents, click Yes.
Click Create major versions, or other settings as needed by your company’s policies and procedures.
Once you click Submit for the Versioning Settings screen, you will be returned to Document Library >
Document Library Settings screen.
This turns on the audit trail functionality, which allows users to be able to view the audit trail of the system
through simple reports. In the Document Library those changes can be reflected in the document view itself
on a document by document basis.

For Centralized Audit Reporting, an administrator would need to turn on this feature under Site Actions >
Site Settings > Site Collection Audit Settings.
Configure Document Templates for Workflow and Signatures

In order to set the document templates needed for electronic signatures, click on Advanced Settings in the
Document Library > Document Library Settings screen.

In Document Library > Document Library Settings > Advanced Settings Screen, click Edit Template in
the Document Template section under the Template URL: dialog.
This will launch the template editor in Microsoft Word. Click on the Insert tab in the Ribbon Bar. On the
Insert Tab, click on the Quick Parts > Document Property dialog and pull-down.

Drag and drop the fields DateSigned, DocumentStatus, PurposeOfSignature,Username and other fields
added to the document library to support electronic signatures.
This then results in a document that has a signature line added in through metadata.
Note that this document, once signed, can be protected via Rights Management Service so that it cannot be
modified once signed, even if e-mailed or a thumb drive used to copy the document elsewhere.
Once Rights Management has been set up for a SharePoint site, setting rights on any given document is as
simple as having the document inserted or created in a document library with specific rights.
Those permissions—or rights—are then inherited by all the documents in that library, or items in a list. This
means that with the appropriate rights set on the document library, as shown in this document, you have the
ability to lock down documents—with or without a formal records declaration—and prevent those
documents from being changed by those without permissions.

Create Workflows for Electronic Signatures
In order to create the workflows necessary to support electronic signatures, you will need to open
SharePoint Designer.
Once in SharePoint Designer, click on the File tab, then the Open Site button. If the site is displayed in the
Recent Sites, then click to open that site.

To create an electronic signature workflow, click on the Workflows link under Navigation > Site Objects.
Once the workflow tab is open, click on the Workflows tab in the Ribbon Bar, and then click on the List
Workflow button.
To configure the workflow for the electronic signature document library, click on the appropriate document
library name in the List Workflow pull-down.

In creating the workflow, the first step is to add condition checks for Approval Status. This will use the
Content Approval Status column in the list library. This condition check will determine if the document is
Approved, Rejected, or if the document is already signed.

You can then define the e-mail message that can be sent to the users involved in the workflow. This is
configured through steps during the SharePoint design Workflow creation process. (See Define E-mail
Message below.)
To do this, simply go to Actions > Send an Email.

Note, again, that the document, when placed into a library can inherit the permissions – and Information
Rights Management Policies through RMS. Since RMS is not an inherently necessary part of Part 11
compliance, please see the MSDN documents on the topic.
Create a Signature Page

The one area of SharePoint that requires customized code to comply with current guidance on 21 CFR Part
11 is on the Signature Page.
Many other federal regulations utilize electronic signatures. But 21 CFR Part 11 is the only one with a
concept of a signing password , where the user re-authenticates in order to validate the signing event. In
most other federal regulations, it is sufficient for the user to a) be authenticated and then during the signing
event simply type in their full name as evidence that they are signing the record.
To meet the re-authentication for the signing event, in this case, simply requires 12 lines of code. Creating
the signing page with all the buttons requires more code—but that can be done through other methods
besides code, including SharePoint designer. The primary step here is attaching the authentication code to
the workflow
The code itself is relatively straightforward. Written in C#, the basic idea of the code is to take the users
username and password and authenticate against LDAP—this is done in the ValidateActiveDirectoryLogin
function below:
/// <summary>
/// Method to validate user for a given credentials
/// </summary>
/// <param name= domain ></param>
/// <param name= username ></param>
/// <param name= password ></param>
/// <returns>Boolean returns true if success</returns>

protected Boolean ValidateActiveDirectoryLogin(string domain, string
username, string password)
{
Boolean success = false;
System.DirectoryServices.DirectoryEntry Entry = new

System.DirectoryServices.DirectoryEntry( LDAP:// + domain, username, password);
DirectorySearcher searcher = new DirectorySearcher(Entry);
searcher.SearchScope = System.DirectoryServices.SearchScope.Subtree;
try
{
searcher.Filter = (SAMAccountName= + username + ) ;
searcher.PropertiesToLoad.Add( cn );
System.DirectoryServices.SearchResult results =
searcher.FindOne();
// userFullName = results.GetDirectoryEntry().Properties[ CN
].Value.ToString();
success = (results != null);
}
catch (Exception ex)
{
success = false;
lblMessage.Text = Error: + ex.Message;
}
return success;
}
Full source code for all the functions will be provided as an appendix to this whitepaper.
Using the provided source code, the signature page appears as follows.

Though not required, as the signature is stored with the document in SharePoint, it is a nice touch that helps
users know that a signature has been applied to a given document. Thus, in the solution provided, code was
added to append the signature to the document itself. In addition, the document is protected by rights
management as part of the workflow cycle, so that no changes can be made to the document once signed.
It is important to note that this is still an electronic signature and not a digital signature. The configuration
methods for digital signatures are provided later in the document.

Set Permissions for the Document Library
SharePoint 2010 has the ability to set permissions on the Document level, Document Library level and site
level.
To set permissions for a document library, navigate to your document library, and then click on Library >
Library Permissions.
Set Policies for the Document Library

One of the more important aspects of configuring SharePoint 2010 for 21 CFR part 11 compliance is
configuring site wide policies that dictate permission levels and rules. This is done to prevent users
particularly content administrators from changing permission levels that would invalidate the compliance of
any given document library.
To configure site wide auditing:
Go to Site Actions > Site Settings > Site Collection Audit Settings
To add stage properties for a document library go to Document library settings > Information
Management Policy Settings.

Click Change Resource link to change staging properties for the documents library.

On clicking the hyper link Add Retention stage the below popup will be shown to configure the document
into Records Center.
Note that the Content Organizer can also be used to send records into the records center that are subject to
Part 11 compliance based on their content-type.

Once delivered to its final destination after approval, the document is automatically declared a record.

Navigate to Site Actions > Site Settings > Record Declaration Settings for globally setting this
throughout the site.
The last step in the process is creating the Custom Permission Levels for Site Roles, so Versioning, Content
Approval Settings, and Workflow can’t be manipulated.

This is an important consideration for Part 11 compliance, as it assures – with proper configuration – that the
audit histories, electronic signatures and other vital information for compliance is not changed in any
fashion.
This configuration of SharePoint and workflow has all records transferred to their preferred locations via the
records retention policies based on the Signed Doc attribute. When the Document becomes approved, then
the attribute is set as a record inside the workflow.
For more information on the process of transferring signed documents to the records center, see
http://technet.microsoft.com/en-us/library/ee424395.aspx

Once in the target document library, click on the Library tab in the Ribbon Bar. This brings you to the
Document Library Settings page which enables you to add the necessary columns for electronic signatures.
The following columns will be added, which include the single signature columns as well as additional
columns for multiple signatures:
 Username
 Purpose of Signature
 Date Signed
 Signers
 Additional fields as outlined below.
The steps for setting version history and version control are the same as for creating single electronic
signatures.
Configure Document Templates for Workflow and Multiple Signatures

In order to set the document templates needed for multiple electronic signatures in a single document, click
on Advanced Settings in the Document Library > Document Library Settings screen.

In Document Library > Document Library Settings > Advanced Settings Screen click Edit Template in
the Document Template section under the Template URL: dialog.
This will launch the template editor in Microsoft Word. Click on the Insert tab in the Ribbon Bar, and then
click on the Quick Parts > Document Property dialog and pull-down.
Drag and drop the fields DateSigned, DocumentStatus, PurposeOfSignature, Username and other fields
added to the document library to support electronic signatures.

This then results in a document that has a signature line added in through metadata. Note that this
document, once signed, can be protected via Rights Management Service so that it cannot be modified once
signed, even if emailed or a thumb drive is used to copy the document elsewhere.

Create Workflows for Multiple Electronic Signatures
In order to create the workflows necessary to support electronic signatures, you will need to open
SharePoint Designer.
Once in SharePoint Designer, click on the File tab, then the Open Site button. If the site is displayed in the
Recent Sites, then click to open that site.

To create an electronic signature workflow, click on the Workflows link under Navigation > Site Objects.
Once the workflow tab is open, click on the Workflows tab in the Ribbon Bar, then click on the List
Workflow button.

To configure the workflow for the electronic signature document library, click on the appropriate document
library name in the List Workflow pull-down.

In creating the workflow, the first step is to add condition checks for Approval Status. This will use the
Content Approval Status column in the list library. This condition check will determine if the document is
Approved, Rejected, or if the document is already signed.

You can then define the e-mail message that can be sent to the users involved in the workflow.
Go to Actions > Send an Email and configure properties appropriately.

Again, it is important to note that while not necessary for Part 11 compliance, the use of Rights Management
Service in conjunction with SharePoint will ensure that the rights become part of the document itself,
originally applied as part of workflow or when a document is loaded into the document library.

The instructions for updating SharePoint for Information Rights Management can be found on MSDN.

The signature page for multiple signatures is the same as for single signatures.
The final signed document with the signatures appears as follows:

The methods for setting permissions for the document library are the same as for single signatures.
To set permissions for a document library, navigate to the document library, and then click on Library >
Library Permissions.

The methods for setting policies for the document library are the same for multiple signatures as they are for
single signatures.
Digital Signatures Use Case

The following scenarios detail configuring SharePoint 2010 and Office 2010 to use digital signatures based
on X.509 Certificates. Note that the provisioning and deployment of those signatures are outside the scope
of this document.
Configuring Digital Signatures in SharePoint and Office 2010 is far simpler than configuring electronic
signatures and provides a higher level of security and assurance than simple electronic signatures, even with
the added features detailed earlier in this document.
In fact, SharePoint 2010 comes with an out of the box Approval Workflow called a “Collect Signatures”
workflow. This document will utilize a variant of that workflow for the Digital Signatures use case.
Administrator Configuration for Digital Signatures

Similar steps are required for creating workflows for Digital Signatures as they are for Electronic Signatures.
Configure Document Library Templates

Creating the document library templates is essential, as this provides the signature blocks that will be used
during the X.509 certificate signature process.
As with the electronic signatures, you first select the document library that will be used for the Digital
Signatures. When there, click on the Library Tool >Library tab in the Ribbon Bar. This brings you to the
Document Library Settings page which enables you to add the necessary columns for digital signatures.
The following column will be added:

 Date Signed
 Signers
Configure Document Library Version Histories

While digital signatures are more secure than electronic signatures, it is still important to create and set
version histories for the audit trail capabilities of the document library.
The steps for doing this are the same as for configuring electronic signatures.
Configure Document Templates for Workflow and Digital Signatures

Setting the document templates for digital signatures is straight forward. In the Document Library>
Document Library Settings screen, click on Advanced Settings.
In the Document Library > Document Library Settings > Advanced Settings screen click Edit Template
in the Document Template section under the Template URL: dialog.

This will launch the template editor in Microsoft Word.
The first step in adding a digital signature to the document is by going to the Office 2010 BackStage by
clicking on the File tab in the Ribbon Bar. Then under Protect Document click on Add Digital Signature.
Once the Digital Signature is added, you’ll want to navigate to the section of the document that will contain
the signature. To insert the Signature at that location, click on the Insert tab in the Ribbon Bar, and then click
on the Signature Line drop down.

This will enable you to insert a signature block or multiple signature blocks. In addition, this drop down
provides for multiple signature providers. This enables different certificates.
Once inserted, an unsigned signature block – or multiple blocks – looks as such:
The signature block can also be a stamped signature, such as would be done for a SAFE BioPharma logo.
In signing a document, the user is prompted for “Comment” which is generally used as the ‘Purpose for
Signing’. It is also possible to create a custom signature event, such as one for SAFE BioPharma that is
located at http://www.codeplex.com/safe
Once used by the signer, the signature block appears as such:
Note that digitally signing a document also makes that document read-only. Saving the document and
making any changes invalidates and removes the signature (but not the unsigned signature block) from the
document.

Also important to discuss is the role of Rights Management, which can be applied to a document before the
signature process, further protecting the document from change.
Create Workflows for Digital Signatures

Creating workflows that utilize digital signatures is actually more straightforward than for electronic
signatures. These workflows can either be created in SharePoint itself, or through SharePoint Designer.
In fact, as mentioned previously, SharePoint 2010 contains out of the box workflows for digital signatures, in
this called “Collect Signatures”.
The MSDN Article used to configure this part of the document can be found at:
http://office.microsoft.com/en-us/sharepoint-server-help/use-a-collect-signatures-workflow-
HA010154428.aspx
Along with more basic articles on approval workflow: http://office.microsoft.com/en-us/sharepoint-designer-

help/understand-approval-workflows-in-sharepoint-2010-HA101857172.aspx?CTT=1
Add or Change a Collect Signatures Workflow

Before a Collect Signatures workflow can be used, it must be added to a library or content type to make it
available for document or items in a specific location.
The Collect Signatures workflow is intended primarily for use in libraries and can be started only on
documents that open in Office Word 2007 or Office Excel 2007. You must have the Manage Lists permission
to add a workflow to a library or content type. In most cases, site administrators or individuals who manage
specific lists or libraries perform this task.
The availability of the workflow within a site varies, depending on where it is added:
 If you add a workflow directly to a library, it is available only for documents in that library.
 If you add a workflow to a list content type (an instance of a site content type that was added to a
specific library), it is available only for items of that content type in the specific library with which
that content type is associated.
 If you add a workflow to a site content type, that workflow is available for any items of that content
type in every list and library to which an instance of that site content type was added. If you want a
workflow to be widely available across libraries in a site collection for items of a specific content
type, the most efficient way to achieve this result is by adding that workflow directly to a site
content type.
Add or Change a Collect Signatures Workflow for a Library or Content Type

If you want to add a Collect Signatures workflow to a library or content type, or if you want to change a
Collect Signatures workflow that is already associated with a library or content type, you follow the same
steps.
1. To go to the Add a Workflow page or the Change a Workflow page for the library or content
type to which you want to add a workflow, do one of the following:
 For a Library:
1. Open the library to which you want to add or change a workflow.

2. On the Settings menu, click the settings for the type of library that you are opening. For
example, in a document library, click Document Library Settings.

3. Under Permissions and Management, click Workflow settings.
 For a List content type:
1. Open the library that contains the instance of the list content type for which you want to
add or change a workflow.
2. On the Settings menu , click the settings for the type of library that you are opening. For
example, in a document library, click Document Library Settings.
3. Under Content Types, click the name of the content type.

 For a site content type:
1. On the home page for the site collection, on the Site Actions menu, point to Site
Settings, and then click Modify All Site Settings.
2. Under Galleries, click Site content types. \

3. Click the name of the site content type for which you want to add or change a workflow,
and then click Workflow settings.
Note: If workflows have already been added to this library or content type, this step takes
you directly to the Change Workflow Settings page, and you need to click Add a
workflow to go to the Add a Workflow page. If no workflows have been added to this
library or content type, this step takes you directly to the Add a Workflow page.
4. On the Change Workflow Settings page, click Add a workflow or click the name of the
workflow for which you want to change the settings.
2. Do one of the following:
 If you are adding a workflow, on the Add a Workflow page, in the Workflow section, click the
Collect Signatures workflow template.
 If you are changing the settings for a workflow, on the Change a Workflow page, change the
settings that you want to change according to the following steps.
 In the Name section, type a unique name for the workflow.
 In the Task List section, specify a tasks list to use with this workflow.
Note: You can use the default Tasks list or you can create a new one. If you use the default
Tasks list, workflow participants will be able to find and view their workflow tasks easily by
using the My Tasks view of the Tasks list.
If the tasks for this workflow will reveal sensitive or confidential data that you want to keep
separate from the general Tasks list, you should create a new tasks list.
If your organization will have numerous workflows or if workflows will involve numerous tasks,
you should create a new tasks list. In this instance, you might want to create tasks lists for each
workflow.
 In the History List section, select a history list to use with this workflow. The history list
displays all of the events that occur during each instance of the workflow.
 You can use the default History list or you can create a new one. If your organization will have
numerous workflows, you might want to create a separate history list for each workflow.
 In the Start Options section, specify how, when, or by whom a workflow can be started.
Notes: Specific options may not be available if they are not supported by the workflow
template that you selected.

The option Start this workflow to approve publishing a major version of an item is
available only if support for major and minor versioning is enabled for the library and if the
workflow template that you selected can be used for content approval.
 If you are adding this workflow to a site content type, specify whether you want to add this
workflow to all content types that inherit from this content type in the Update List and Site
Content Types section.
Note: The Update List and Site Content Types section appears on the Add a Workflow page
only for site content types.
3. Click OK.
Start a Collect Signatures Workflow on a Document or Workbook
Before you can start a Collect Signatures workflow, you must save the document or workbook for which you
want to collect signatures to a SharePoint library for which the Collect Signatures workflow is available. You
must have at least the Edit Items permission to start a workflow. Some workflows may require that you also
have the Manage Lists permission in order to start a workflow on a document or item.
Note: If you want to ensure that workflow participants receive e-mail notifications and reminders about their
workflow tasks after you start a workflow, check with your server administrator to verify that e-mail
notifications have been enabled for your site.
1. If the library is not already open, click its name on the Quick Launch. If the name of your library
does not appear, click View All Site Content, and then click the name of your library.
2. Point to the document or workbook on which you want to start a Collect Signatures workflow, click
the arrow that appears, and then click Edit in Program Name.
3. If the document or workbook does not already contain signature lines to capture the digital
signatures that you want to collect, insert them now as described previously and repeated below. If
you add new signature lines, click the File tab, and then click Save to save your changes.
4. If the document is checked out, you must also check in the document before you start the
workflow. To check in the document, click the File tab, point to Server, and then click Check In.
5. For the user to start the workflow, click the File tab, and then click Workflows. In the Workflows
dialog box, locate the Collect Signatures workflow that you want to use, and then click Start.
6. In the Workflow Name dialog box, type the names of the people you want to sign the document
on the appropriate signers lines, or click Signer to select people from the directory service.
7. If you want to assign the signature tasks in the order in which signature lines appear in the
document, select the Request signatures in the order above, rather than all at once check box.
8. If you want other people to receive notifications (not task assignments) when the workflow is
started, type their names on the CC line, or click CC to select people and groups from the directory
service.
9. Click Start.

Starting with Office 2007 and continuing with Office 2010, Signature Pages for Digital Signatures are out-of-
the-box.
To sign a document, right click on the Signature Block as shown above, select the certificate to be used,
provide the reason for signing, and click OK.

You will be prompted for your Digital Certificate PIN and/or to insert your SmartCard or Token. Once the PIN
is authenticated against the card or token, the signature is placed within the document and the document is
made read-only.
The only change that can be made to a signed document is to add another signature.

These steps are the same as for electronic signatures.

These steps are the same as for electronic signatures.
View the Version Histories for Digital Signatures

Auditing digitally signed documents can be done in a couple ways: within the document itself as XAdES
requires the signing history be kept with the document and also through the SharePoint version history.
To view additional information and signature history of the document:
1. Open the file that contains the signatures that you want to view.
2. Click the File tab. The Microsoft Office Backstage view opens.
3. Click the Info tab.
4. Click View Signatures.
5. The Signatures pane appears with a list of signatures.
The following image is an example of the Signatures pane.
6. In the Signature pane, next to the signature name, click the down arrow and select Signature
Details.

7. The Signature Details dialog appears. Click See the additional signing information that was
collected.
8. The Additional Information dialog appears.

The following image is an example of the Additional Information dialog.
The following signature information appears:
 What the signature signs
 Local date and time the signature was applied
 The version of the Microsoft Windows operating system installed
 The version of Microsoft Office installed
 The version of the Microsoft Office program used
 The number of monitors installed
 Monitor resolution
You can view the message that indicates the file is not showing hidden content.

21 CFR Part 11 Requirements
Subpart B Addressed / Not Addressed
11.10 Controls for closed systems Addressed
11.10 (a) Validation of systems Addressed
11.10 (b) Record review and inspection Addressed
11.10 (c) Records protection and retrieval Addressed
11.10 (d) System access Addressed
11.10 (e) Audit trail Addressed
11.10 (f) Operational system checks Addressed
11.10 (g) Protect record from unauthorized access Addressed
11.10 (h) Data input validation Addressed
11.10 (i) Personnel training Not applicable
11.10 (j) Electronic signature policy Addressed
11.10 (k) System control Addressed
11.30 Controls for open system Addressed
11.50 Signature manifestation Addressed
11.50 (a) Signature information Addressed
11.50 (b) Control of signature information Addressed
11.70 Signature/record linking. Addressed
Subpart C
11.100 General requirements. Not applicable
11.100 (a) Uniqueness Not applicable
11.100 (b) Identity verification Not applicable
11.100 (c) Legal certification Not applicable
11.200 Electronic signature components and controls Addressed
11.200 (a) Non-biometric signature Addressed
11.200 (b) Genuine use of biometrics signature Not applicable
11.300 Controls for credentials Addressed
11.300 (a) Maintain of credentials uniqueness Addressed
11.300 (b) Credential maintenance Addressed
11.300 (c) Process for lost or compromised credentials Addressed
11.300 (d) Safeguard to unauthorized credential use Addressed
11.300 (e) Device maintenance Not applicable

Subpart B Electronic Records
11.10 Controls for Closed Systems
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ
procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the
confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record
as not genuine.
As the previous configurations demonstrate, SharePoint Server addresses authenticity, integrity and
confidentiality of electronic records through access control and permission to the records on either the
individual record level or a document library level. Users are assigned permissions to content and records
through permissions which limit what they can do by administrators. Documents identified as records can be
sent to a record center for safe keeping and have separate access control than when the document was
authored and reviewed.
To protect confidentiality of an electronic record, documents can be protected by Information Rights
Management (IRM) policy that could restrict users from copying or printing documents even after the
document is saved outside of the SharePoint Server.
SharePoint also addresses non-repudiation through audit trails as demonstrated. The auditable system of
records are implemented through policies which can be configured for documents and items in Office
SharePoint Server 2010 to specify which events will be audited for each Content Type or site level, via the
Information Management Policy capabilities. An audit trail is kept with a document throughout the
document and record life cycle.
11.10 (a) Validation of Systems

Systems validation ensures accuracy, reliability, consistent intended performance, and the ability to discern
invalid or altered records.
How Office 2010 System Addresses the Requirement

Addressing this requirement takes a couple forms: 1) Validation of the system as a whole, and 2) validation
of the individual documents or records.
To address validation of the system, there are three areas of validation that implementing parties need to be
concerned with: IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance
Qualification).
In the case of Installation Qualification, the focus is on ensuring that the application is installed correctly, and
all Microsoft product generated installation logs are maintained which detail the installation as well as any
errors that may arise during the installation process.
In addition, Microsoft Systems Center can provide installation audit trails for SharePoint implementations to
ensure that all components installed properly.
Operational Qualification begins with the development methodology utilized to create the software. Most
Microsoft products, and all the products detailed in this whitepaper, adhere to the Security Development
Lifecycle methodology. This methodology, which encompasses steps traditionally employed in software
development methodology, places a particular focus on development of software that is secured by design,
in development, and through implementation. All major software releases from Microsoft, beginning with
the Office 2007 and Vista/Longhorn wave of software releases are required to go through the internal

processes and checkpoints detailed in the Security Development Lifecycle methodology, and must be signed
off on by a Security Officer before the particular software can be released to the general public.
The details of the methodology are available on MSDN as well as through published works by Steve Lipner
and Michael Howard (see the Reference section for more information).
In addition, there is a whitepaper available entitled “Mapping Microsoft Development Methodology to the
V-Model” that is available on MSDN as well.
Operational Qualification extends to the operation of the software. To that end, most Microsoft software,
and all the products detailed in this whitepaper, provide detailed error logging and troubleshooting
information that can be gained through a proper implementation of the Microsoft Systems Center
Operations Manager. In fact, any software release must include a management pack for Operations Manager
before the particular software can be released to the general public.
The details of the management pack for all relevant software are available in the References section of this
document.
Performance Qualification always includes the question, “Does the software perform to the end users’
needs?” As that question can only be answered by the implementing party, the final step in validation of the
software needs to be the development of test plans and testing of the software in the environment in which
it will be utilized. These test plans can be modeled on this whitepaper to assist with the proper configuration
of the software.
While the overall validation of the software is up to the implementing party, Microsoft has assisted in the
validation through the creation of the development methodology, implementation of management packs,
implementation of the installation logs, and development of this whitepaper to give guidance in the
configuration of the software and development of the test plans for performance qualification.
Finally, Microsoft recommends that companies periodically audit their own implementation of the software,
in order to ensure that the guidelines specified herein are applied to their production systems and are
enforced throughout.
To address validation of the individual documents, SharePoint provides auditing features to facilitate the
validation process.
As SharePoint server is designed as an auditable system, the administrator can configure the system to audit
document creation, specifically document modification and deletion among other things so all changes to a
document are audited. Additionally, you can also extend the auditing capabilities to include additional
information such as version and workflow status.
All these capabilities related to SharePoint were demonstrated in the configurations detailed in the use cases
section of this Whitepaper
11.10 (b) Record Review and Inspection

The ability to generate accurate and complete copies of records in both human readable and electronic form
suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are
any questions regarding the ability of the agency to perform such review and copying of the electronic
records.

As shown in the configuration methods, SharePoint has the ability to generate accurate and complete copies
of records in both human readable and electronic form.
Additionally, when the documents in question are written in the Microsoft Office 2010 system, the OpenXML
file format allows the document to be accessible electronically (i.e. machine readable in XML in its
component parts) while still maintaining the ability to be viewed as a whole through Word, Excel, or
PowerPoint as appropriate. Saving the document in XML Paper Specification (XPS) format provides the best

of both worlds: a machine readable document (in XML) whose formatting does not change regardless of the
printer, screen, or viewing application used to display the document.
For a description of the OpenXML format, refer to http://www.ecma

international.org/publications/standards/Ecma-376.htm
For a description of the XML Paper Specification (XPS), refer to

http://www.microsoft.com/whdc/xps/downloads.mspx
Both XPS and OpenXML are native file formats for Office 2010 and are understood and readable by the
Windows 7 operating system as well.
Agencies and inspectors can be given read-only access to documents during the review process. Electronic
documents will be viewed either natively or in other formats via document converters or viewers.
11.10 (c) Records Protection and Retrieval

Protection of records to enable their accurate and ready retrieval throughout the records retention period.

As discussed in the configuration section, SharePoint 2010 protects documents through content policies that
prevent documents from being changed. In addition, the system then takes the documents declared as
records and can flag them for retention for a specific period of time.
1. Automatically receive/route records declared from other sources—Records Centers are able to
determine how the Content Type of a declared record translates to an appropriate record series in
the file plan, and then file the record into the appropriate location.
2. Hold orders: The Records Center includes a powerful hold order system to locate records relevant
to particular event requiring a hold order, suspending disposition of those records for the duration
of the event, and for resuming normal disposition once those events have ended.
3. Separate access controls: Records Center can give you the flexibility to specify whether users can
access any section of the Records Center, whether they can view or add items, independent of the
permissions those users have on authoring and collaboration sites.
As demonstrated, documents can be attached to a policy that defines content expiration and version control
policy.
Microsoft Office technology allows content that is outside the repository to be secured on the basis of
policies as well by using the Rights Management Server. With the 2010 system, an access control policy set
up for a SharePoint site can also be maintained for documents on the desktop. These rights also extend to
expiration, printing, forwarding, and copying, thereby ensuring a higher level of content security than has
been possible with traditional approaches.
11.10 (d) System Access

Limiting system access to authorized individuals.

SharePoint sites containing information or documents to be protected should not allow anonymous access.
The User will need to be authenticated before access to the site is granted.
The following are authentication methods for SharePoint (or any ASP.NET application):
 Windows integrated (NTLM, Kerberos, or certificate) – user is authenticated when they log on their
computer. This is enforced by IIS.

 Basic authentication – user enters domain credentials for authentication before access to the site is
granted. This is enforced by IIS. As credentials are sent as plain text by default, this option should
use SSL or other mechanism to encrypt the http traffic.
 Forms based or SSO – user enters credentials assigned to them that may not be their domain
credentials. As with Basic Authentication, HTTP traffic needs to be encrypted to protect the
credentials. This requires additional settings on web.config file for the web application.
Authentication setting is set per web application (the container that hosts portal and collaboration sites) and
is configured through SharePoint Central Administration Application.
The following is a sample web.config file used to setup forms-based authentication, role-based access, and
denies access to unauthenticated users:
<configuration>
<connectionStrings>
<add name= MySqlConnection connectionString= Data
Source=MySqlServer;Initial Catalog=aspnetdb;Integrated
Security=SSPI; />
</connectionStrings>
<system.web>
<authentication mode= Forms >
<forms loginUrl= login.aspx

name= .ASPXFORMSAUTH />
</authentication>
<authorization>
<deny users= ? />

</authorization>
<membership defaultProvider= SqlProvider userIsOnlineTimeWindow= 15 >
<providers>
<clear />
<add
name= SqlProvider
type= System.Web.Security.SqlMembershipProvider
connectionStringName= MySqlConnection
applicationName= MyApplication
enablePasswordRetrieval= false
enablePasswordReset= true
requiresQuestionAndAnswer= true
requiresUniqueEmail= true
passwordFormat= Hashed />
</providers>

</membership>
<roleManager defaultProvider= SqlProvider
enabled= true
cacheRolesInCookie= true
cookieName= .ASPROLES
cookieTimeout= 30
cookiePath= /
cookieRequireSSL= false
cookieSlidingExpiration= true
cookieProtection= All >
<providers>
<add
name= SqlProvider
type= System.Web.Security.SqlRoleProvider
connectionStringName= MySqlConnection
applicationName= MyApplication />
</providers>
</roleManager>
</system.web>
</configuration>
After authentication, the user will also need to be assigned appropriate rights to access specific features and
contents. Details on how to configure user roles and rights are discussed in Section 11.10 (g) of this paper.
11.10 (e) Audit Trail

Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of
operator entries and actions that create, modify, or delete electronic records. Record changes shall not
obscure previously recorded information. Such audit trail documentation shall be retained for a period at
least as long as that required for the subject electronic records and shall be available for agency review and
copying.

As discussed in 11.10 (a) audit trails in SharePoint are provided at the document level, document library level
and at the site level. These capabilities were demonstrated in the configuration section of this document.
11.10 (f) Operational System Checks

Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate

As demonstrated in the configuration section, SharePoint 2010 can enforce workflow, audit trails and
electronic signatures on any given document.
11.10 (g) Protect Records from Unauthorized Access

Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a
record, access the operation or computer system input or output device, alter a record, or perform the
operation at hand.

As demonstrated, SharePoint Server 2010 controls access to Web sites, lists, folders, and list items through a
role-based membership system by which users are assigned to roles that authorize their access to Windows
SharePoint Services objects. The creation and authentication of the user and to which role the user is
assigned is discussed in Section 11.300 – Controls for Identification Codes / Passwords.
To give a user access to an object, you either add the user to a group that already has permissions on the
object, or create a role assignment object, setting the user for the role assignment and then adding the
assignment to the collection of role assignments for the object (such as list item, folder, list, or Web site).
By default, objects inherit permissions from their parent (document from document library or folder,
document library from site, site from parent site).
Following are the screen shots of defining a unique permission setting for a document.
11.10 (h) Data Input Validation

Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or
operational instruction.

Transport level encryption (such as SSL) can be used to secure the content (data input) from users.
ASP.NET (which SharePoint is built on) uses the Message Authentication Code (MAC) technique to protect
key information, such as view state data and authentication tickets, to make sure that the data are not
illegally modified.
For cookie-based authentication (such as forms authentication), administrators can configure cookie timeout
parameters to be reasonably short to reduce the cookie reply security risk.
For additional protection, Microsoft has developed Forefront Security for SharePoint, which helps businesses
protect their Microsoft Office SharePoint Server 2010 servers from viruses, unwanted files and inappropriate
content. With a layered, multiple scan engine approach, Forefront Security for SharePoint helps stop the
latest threats before they impact your business and users.
11.10 (i) Training

Determination that persons who develop, maintain, or use electronic record/electronic signature systems
have the education, training, and experience to perform their assigned tasks.

Microsoft product teams follow rigorous development and testing processes for its product development
including the Office 2010 systems, as described in Section 11.10(a) Validation of Systems.

Microsoft and many of its partners offer extensive training courses, technical resources, and certifications for
.NET, SharePoint and related technologies to help organizations to educate and train their people for specific
tasks.
11.10 (j) Electronic Signature Policy

The establishment of, and adherence to, written policies that hold individuals accountable and responsible
for actions initiated under their electronic signatures, in order to deter record and signature falsification.

While the establishment of a Electronic Signature Policy is the responsibility of the implementing
organization, the Office 2010 can assist in the adherence to those written policies by implementing Records
Management that reflect and enforce those policies.
Creating a successful Records Management system starts with mapping out the organization’s records
management goals, anticipating the challenges an organization will face in making that vision a reality within
the company, and developing a policy and implementation that fits these needs. Since planning is a key to
both the policy development and solution implementation phases, it is important to outline the challenges
faced at each stage so these can be kept top of mind when working out both the organization policy plan
and implementation strategy.
At the policy planning stage, the major challenge is to devise a system that encompasses an organization’s
current records-keeping needs: content types, media types, storage requirements, business processes, and
policies. It also needs to meet present legal and audit requirements, and be extensible and flexible enough
to accommodate future content types and retention requirements. Another important goal is to enhance
information retrieval, which will help employees do their jobs more efficiently and give an organization a
competitive advantage.
In developing the policy for an organization, the challenge is to create an overarching policy document that
is comprehensive but short, easy to read, and accompanied by actionable retention schedules that can then
be put into practical use. Furthermore the policy needs to be integrated with the organization’s other
enterprise content management policies, and be able to absorb and integrate previous record keeping
efforts.
At the implementation stage, the major challenge is to create a system that suits the organization’s
workflow, one that will actually be adopted by users and integrated into their daily activities. The
implementation must be simple enough for employees to grasp quickly, easy enough to require only few
extra steps (or clicks), but rigorous enough to meet the organization’s overall need for record keeping within
the organization. Furthermore, any technology rollout must be manageable for the organization as a whole –
and not significantly disrupt normal business operations.
SharePoint Server 2010 includes multiple information management policy features to help an organization
manage content type as shown in Section 11.10 (c):
 Document expiration
 Document auditing
 Document labels
 Document bar codes
11.10 (k) System control

Use of appropriate controls over systems documentation including:
(1) Adequate controls over the distribution of, access to, and use of documentation for system operation
and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced
development and modification of systems documentation.
How Office 2010 System and Rights Management Services (RMS) Address the
Requirement
Microsoft Active Directory Rights Management Services (RMS) augments an organization’s security strategy
by providing protection of information through persistent usage polices, which remain with the information.
Content is protected with RSA 1024-bit Internet encryption and authentication so that information will be
safe in transit and will remain with the document, no matter where it goes. For example, encrypted content
stored on a lost USB drive will not be accessible and viewable to any unauthorized viewer, regardless of
location.
This information protection technology works with RMS–enabled applications to help safeguard digital
information from unauthorized use—both online and offline, inside and outside of the firewall. Record
managers and administrators can define exactly how users can use data and can place limitations on who
can open, modify, print, copy, and forward certain confidential information.
Revision and change control can be enforced through checkout and audit trail policies as discussed
previously in this document.
11.30 Controls for Open Systems

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ
procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation to the point of their receipt.
Such procedures and controls shall include those identified in Section 11.10, as appropriate, and additional
measures such as document encryption and use of appropriate digital signature standards to ensure, as
necessary under the circumstances, record authenticity, integrity, and confidentiality.

SharePoint can leverage the underlying ASP.NET infrastructure to authenticate users through various means
which are discussed in Section 11.300 – Controls for Identification Codes / Passwords. Together with SSL (or
other transport level security measures), user access and data transport can be secured from the point of
creation to the point of receipt.
Office 2010 enables three use-case scenarios with the out-of-the-box digital signature functionality to
protect documents starting from their point of creation.
 Authenticity & Tamper Resistance: Signing an Office document to prove that it hasn’t been
modified since it was signed. You can also view the digital certificate used to sign the document to
verify the authenticity of the document and prove that it came from a trusted individual or
organization.
 Digital Signature: Signing an Office document with both a specific identity and an assertion about
why this document was signed (for example, “Approved for Publication”). This type of signature
does not print with a document and does not affect the on-page content of a document, but can
be viewed and verified with software, including Office 2010 applications.
 In Document Signature: Signing an Office document in a special signature line object that visually
shows who signed the document. This feature is designed to mimic the experience of pen and ink
signatures. It is this type of signature that was created in the earlier configuration of electronic
signatures discussion.
As discussed, Office 2010 documents support digital signatures out of the box and are extensible. For digital
signature of non-office based documents, there is third-party vendor support in the market place.

In addition to the digital signature controls and SSL used to transmit the electronic record, Forefront Security
for SharePoint can provide further assurance that the record is valid by protecting Microsoft Office
SharePoint Server 2010 servers from viruses, unwanted files and inappropriate content.
11.50 Signature Manifestations

11.50 (a) Signature Manifestation
Signed electronic records shall contain information associated with the signing that clearly indicates all of
the following:
1. The printed name of the signer;
2. The date and time when the signature was executed; and
3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

As demonstrated in the configuration example, SharePoint 2010 can use workflow to enforce document
approval and signoff. Information collected during the approval and signoff process can be customized to
include all information required under this rule and more. Custom solutions built on top of the Office
SharePoint Server 2010 can also add relevant entries to the audit log, such as when an approval workflow is
completed.
11.50 (b) Control of signature information

The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls
as for electronic records and shall be included as part of any human readable form of the electronic record
(such as electronic display or printout).

Office 2010 documents store digital signatures as a separate stream from the content stream and are part of
the document package. In compliance with XAdES, the entire signature process, including the validity of the
signature at time of signing is kept with the document package. In addition, ss shown in previous screen
shots, the digital signature of an Office 2007 document can mimic the paper and ink signature experience.
In the case of Electronic Signatures, the signature, date and time of signature, and the signature meaning are
linked to the document through metadata that is associated with the document in SharePoint; are kept with
and linked to the document throughout the document life cycle; and can be viewed with the document in
SharePoint. As demonstrated, it is possible to integrate the metadata into the body of the document, as it
would appear in a printed version of the document, through the use of a document template that reads the
metadata from SharePoint, stores the metadata in the document as part of the OpenXML, and then allows
for display of the metadata inline in the document.
11.70 Signature/Record Linking

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their
respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise
transferred to falsify an electronic record by ordinary means.

Digital signatures for Office 2010 documents are stored as part of the document. As demonstrated earlier,
Office 2010 provides a task pane to help users view and verify the signatures stored within a document. This
pane is designed to differentiate signatures based on whether they are requested, valid, or invalid. This task
pane is a built-in part of the signature platform and automatically displays information about the signature
objects regardless of whether they come from our built-in implementation or a custom written signature
add-on.
Electronic signature and approval information are stored as part of the audit trail and metadata associated
with the document. The linkage between signature and document is maintained by the server and can be
read in the document through document templates as discussed in the previous section.
Digital signature and approval information are stored as part of the audit trail and metadata associated with
the document when signed as part of a workflow.
Subpart C Electronic Signatures

11.100 General Requirements
11.100 (a) Uniqueness
Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to,
anyone else.

Policies and procedures should be developed to verify each user’s identity prior to a user being assigned a
username and password and to dictate that users should not share credentials. These policies and
procedures should be included as part of the compliance and system training process.
The creation, maintenance, and authentication of the user are discussed in Section 11.300 – Controls for
Identification Codes / Passwords.
11.100 (b) Identity Verification

Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic
signature, or any element of such electronic signature, the organization shall verify the identity of the
individual.

This should be part of the compliance solution planning and training process.
11.100 (c) Legal Certification

Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the
electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding
equivalent of traditional handwritten signatures.
1. The certification shall be submitted in paper form and signed with a traditional handwritten
signature, to the Office of Regional Operations (HFC 100), 5600 Fishers Lane, Rockville, MD 20857.

2. Persons using electronic signatures shall, upon agency request, provide additional certification or
testimony that a specific electronic signature is the legally binding equivalent of the signer's
handwritten signature.

In addition to this being part of the compliance solution planning process, a step can be added to the
signing workflow to verify that a certification check is in place (by looking at a lookup list of authorized
signers).
11.200 Electronic Signature Components and Controls

11.200 (a) Non-biometric Signatures
1. Electronic signatures that are not based upon biometrics shall:
a. Employ at least two distinct identification components such as an identification code and
password.
b. When an individual executes a series of signings during a single, continuous period of

controlled system access, the first signing shall be executed using all electronic signature
components; subsequent signings shall be executed using at least one electronic signature
component that is only executable by, and designed to be used only by, the individual.
2. When an individual executes one or more signings not performed during a single, continuous
period of controlled system access, each signing shall be executed using all of the electronic
signature components.
3. Be used only by their genuine owners; and
4. Be administered and executed to ensure that attempted use of an individual's electronic signature
by anyone other than its genuine owner requires collaboration of two or more individuals.

SharePoint supports variety of authentication mechanisms supporting 2 factor schemes (combination of user
id and password). This includes windows integrated (NTLM and Kerberos) authentication, basic
authentication, forms authentication as well as Claims Based Authentication using SAML 2.0 tokens.
11.200 (b) Biometric Signatures

Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone
other than their genuine owners.
How Microsoft Windows and Office 2010 Addresses the Requirement

There are third-party vendors who provide biometric-based authentication to the Windows system, including
most major hardware vendors. With respect to the Microsoft Office 2010 system, a biometric identity is
handled as any other identity, as the biometric information is associated with either a username or a digital
certificate. Regardless, a password is still required for authentication (in the case of electronic signatures), or
a PIN is required for authentication (in the case of a Digital Certificate).
11.300 Controls for Identification Codes/Passwords

Persons who use electronic signatures based upon the use of identification codes in combination with
passwords shall employ controls to ensure their security and integrity. Such controls shall include the
following:

11.300 (a) Uniqueness of identity
Maintaining the uniqueness of each combined identification code and password, such that no two
individuals have the same combination of identification code and password.
How Microsoft Windows and Active Directory Addresses the Requirement

This is enforced by Windows or Active Directory if using integrated authentication and Basic authentication
in an organization’s SharePoint setup.
For detailed discussion as well as a step-by-step configuration guide of windows accounts and password
policy, please refer to the articles listed in the Reference section of this paper.
For Forms authentication, this is enforced by the authentication provider.
11.300 (b) Password Policy

Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g.,
to cover such events as password aging).
How Microsoft Windows and Active Directory Addresses the Requirement

Windows and Active Directory infrastructure can enforce password policy for complexity and expiration.
Windows integrated authentication and Basic authentication can leverage this automatically.
For detailed discussion as well as a step-by-step configuration guide of windows accounts and password
policy, please refer to the articles listed in the Reference section of this paper.
A similar mechanism will need to be implemented by the authentication provider if Forms authentication is
used.
11.300 (c) Deactivation of Users

Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise
potentially compromised tokens, cards, and other devices that bear or generate identification code or
password information, and to issue temporary or permanent replacements using suitable, rigorous controls.

Windows and Active Directory administrators can deactivate users, change users passwords, or require users
to change passwords after issuing a temporary password. Windows integrated authentication and Basic
authentication can leverage this automatically.
These capabilities can be extended to Digital Signatures through Active Directory and the use of Microsoft
Active Directory Certificate Manager.
11.300 (d) Unauthorized Use of Passwords or Identification Codes

Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to
detect and report on an immediate and urgent manner any attempts at their unauthorized use to the system
security unit, and, as appropriate, to organizational management.

The Microsoft Windows family of products, including Microsoft Windows Server 200 R2 and Windows 7 can
both audit logon changes and failed attempts.

Group policy can enforce account lockout policy to help to prevent brute force password guessing. Lockout
policy is based on failed attempts for a time window and users can be locked out for specified times before
they can attempt again (or not).
Group policy can also enforce password policy to mitigate the risk of unauthorized credential use. Password
policy can be set to enforce complexity of the password (including minimal length and combinations),
password aging (expiration), and password history (reuse of previous passwords).
Similar policies can be extended to Digital Certificates through the use of Microsoft Active Directory
Certificate Services.
11.300 (e) Identification Code Device Testing

Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or
password information to ensure that they function properly and have not been altered in an unauthorized
manner.

This should be part of the operational procedure that is written into the compliance policies and procedures.

Systems Validation and
Compliance
Systems validation and compliance is covered in depth in a Microsoft whitepaper entitled “Validation and
the Microsoft Platform.”
The whitepaper covers the following topics:
 Microsoft software development practices and how they map to the industry v-model
 Installation Qualification methodology using Microsoft tools and system resources

 Operational Qualification methodology using Microsoft tools and system resources
This whitepaper is available on MSDN at the Microsoft Life Sciences Developer Center
(http://msdn.microsoft.com/architecture/lifesciences
The information contained in this document represents the current view of Microsoft Corporation on the issues
discussed as of the date of publication. Because Microsoft must respond to changing market conditions, it should
not be interpreted to be a commitment on the part of Microsoft, and Microsoft cannot guarantee the accuracy of
any information presented after the date of publication.
This white paper is for informational purposes only. Microsoft makes no warranties, express or implied, in this
document.
Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights under
copyright, no part of this document may be reproduced, stored in, or introduced into a retrieval system, or
transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any
purpose, without the express written permission of Microsoft Corporation.
Microsoft may have patents, patent applications, trademarks, copyrights, or other intellectual property rights
covering subject matter in this document. Except as expressly provided in any written license agreement from
Microsoft, the furnishing of this document does not give you any license to these patents, trademarks, copyrights,
or other intellectual property.
© 2012 Microsoft Corporation. All rights reserved.
The example companies, organizations, products, domain names, e-mail addresses, logos, people, places, and
events depicted herein are fictitious. No association with any real company, organization, product, domain name, e-
mail address, logo, person, place, or event is intended or should be inferred.
Microsoft, Microsoft Office 2010, Microsoft SharePoint 2010, Microsoft Word, Microsoft Excel, Microsoft
PowerPoint, Microsoft Rights Management Services, Active Directory, Windows Server 2008 R2, Windows 7,
Windows Vista, Windows XP, Microsoft Windows, Microsoft Certificate Lifecycle Manager, Microsoft Visual Studio,
Microsoft Forefront are either registered trademarks or trademarks of Microsoft Corporation in the United States
and/or other countries.
The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

SharePoint Configuration Guidance For 21 CFR Part 11 Compliance

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SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

Published: April 2012

Health and Life Sciences Industry Unit

Health and Life Sciences Practice

Architectural Approaches to Compliance ................................................................................................ 3

Use Cases for 21 CFR Part 11 Compliance ............................................................................................... 4

Architecture for 21 CFR Part 11 Compliance .......................................................................................... 8

Configuring the Electronic Signature Use Cases ................................................................................ 12

Digital Signatures Use Case ........................................................................................................................ 47

21 CFR Part 11 Requirements ..................................................................................................................... 56

Subpart B Electronic Records ..................................................................................................................... 57

Subpart C Electronic Signatures ................................................................................................................ 66

Systems Validation and Compliance ....................................................................................................... 70

SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

1 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

2 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

 Policies & Workflow

 Managed Metadata and the Taxonomy Term Store

3 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

1. A discussion of configuring SharePoint 2010 for Part 11 compliance

c. Detail the workflow and policies for electronic signatures

d. Detail the workflow and policies for digital signatures

e. The promotion of records to in-place and centrally managed records

Use Cases for 21 CFR Part 11

Electronic Signature Use Cases

Single Signature Use Case

o Update the document library with new columns

o Set the Content Approval Status

4 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

o Utilize SharePoint Designer

o Attach the workflow to the document library

o Create custom security for the content-type

The user will:

 Author the document to make necessary changes

 Save the document to the library

 Sign the document as part of the approval workflow

 View the audit trail (workflow history) of the document library

Multiple Signature Use Case

o Update the document library with new columns

o Set the Content Approval Status

o Create and add document templates for embedded signatures (optional)

o Utilize SharePoint Designer

o Attach the workflow to the document library

 Set the policies for the document template

5 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

 Author the document to make necessary changes

 Submit the document for workflow approval

 Sign the document as part of the approval workflow

 View the audit trail (workflow history) of the document library

Digital Signatures Use Cases

Single Signature Use Case

 Configure document library templates for digital signatures

o Update the document library with appropriate columns for workflow

o Set the Document Version History settings

o Create and add document templates for digital signatures

 Create workflows for Digital Signatures

o Attach the workflow to the document library

 Set the policies for the document template

o Create custom security for the content-type

These configurations will enable the user to:

 Author the document to make necessary changes

6 SharePoint Configuration Guidance for 21 CFR Part 11 Compliance

 Submit the document for workflow approval