Title Validation Summary SOP

Version Status Date Page

1.0 Commercial in Confidence 03-Aug-2006 1 of 9

Validation Summary SOP

Document No: SOP_0700

Prepared by: David Brown
Date: 03-Aug-2006
Version: 1.0
Title Validation Summary SOP
Version Status Date Page
1.0 Commercial in Confidence 03-Aug-2006 2 of 9

Document Approval

Name Role Date Signature

David Brown Author

Document Control

Version Author Date Description

1.0 David Brown 03-Aug-2006 Version 1
Title Validation Summary SOP
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Table of Contents

1 Introduction ............................................................................................................................ 4
1.1 Purpose ........................................................................................................................... 4
1.2 Scope ............................................................................................................................... 4
1.3 Definitions ...................................................................................................................... 4
1.4 Responsibility................................................................................................................. 4
1.5 References ...................................................................................................................... 4
2 Validation Summary Process ................................................................................................. 5
3 Validation Summary - Phase Entry/Exit ............................................................................... 6
3.1 Phase Entry .................................................................................................................... 6
3.2 Phase Exit ....................................................................................................................... 6
4 Validation Summary Report Content - Procedure ................................................................ 7
4.1 Validation Summary Report Title ............................................................................... 7
4.2 Approval......................................................................................................................... 7
4.3 Introduction ................................................................................................................... 7
4.4 Scope ............................................................................................................................... 8
4.5 Definitions ...................................................................................................................... 8
4.6 References ...................................................................................................................... 8
4.7 Computer System Description...................................................................................... 8
4.8 Validation Activity Results ........................................................................................... 8
4.9 Summary of Failures..................................................................................................... 8
4.10 Conclusion ...................................................................................................................... 9
Title Validation Summary SOP
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1 Introduction

1.1 Purpose
This SOP provides guidance for the validation summary process
and the purpose and minimum content requirements for a
Validation Summary Report (VSR).

1.2 Scope
Department/Section: Validation group
This SOP applies to all computer systems requiring validation.

1.3 Definitions
Project Team - The group of associates that come together for
a specific purpose. The group maybe composed of business
clients, Support, Validation, and other areas necessary to the
successful completion of a project.
Client – the business system owner is typically the ‘line’
manager responsible for the business process where the
computer system will be used.
Validation Group – the group responsible for ensuring that
computer systems are implemented and maintained in a
validated state.
IT Group – the group responsible for development, operation,
and maintenance of computer systems.

1.4 Responsibility
Validation and the other disciplines listed within this SOP are
responsible for ensuring this procedure is followed.

1.5 References

Document ID Title
SOP_0400 Design Qualification SOP
SOP_0500 Installation Qualification SOP
SOP_0600 Operational Qualification SOP
SOP_0700 Production Qualification SOP
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2 Validation Summary Process

The validation summary phase is led by the validation group.
The main aim is to summaries the results of the validation
process required for the computer system. The tasks required
during this phase are:
1. The review of the results of each phase of the validation
process (Validation Planning, Design, Installation(s), and
Operational Qualifications);
2. The identification of any issues that where experienced
during the validation process;
3. The identification of any constraints and limitations that
must placed on the systems ability to manage data and
processes related to regulated activities.
4. Identification of the operational SOPs, manuals, and
Production Qualification(s) required ensuring the system
remains validated when live.
5. Preparation of a Validation Summary Report documenting
the outputs of the above activities.
6. The approval of the Validation Summary Report by all of
the stakeholders identified in the validation plan.
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3 Validation Summary - Phase Entry/Exit

3.1 Phase Entry

The entry point for the validation summary process is the
approval of the Production Installation Qualification.

3.2 Phase Exit

The exit point for the validation summary phase is the approval
of the Validation Summary Report.
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4 Validation Summary Report Content -

Procedure
The purpose of the Validation Summary Report (VSR) is to
provide an executive summary of all of the DQ, IQ, OQ,
protocols and other activities described in the appropriate
Validation Plan and which were performed to complete
validation of the computer system. The Validation Summary
Report is approved after formal validation activities have been
completed. The master summary is prepared by members of
the validation group or trained designees. The VSR must
conform to SOP_0102 Document Standards SOP.
At a minimum, the following sections are required in the
Validation Summary Report:

4.1 Validation Summary Report Title

Give the VSR a descriptive title that uniquely identifies the
system.

4.2 Approval
At the beginning of the Validation Summary Report an approval
section is required. This section will contain a table for
signatures. The table of signatures must provide for the
following information to be captured:
1. The department or function of the signatory;
2. The name of the signatory;
3. A space to record the signature, and;
4. A space to record the date of the signature.
The section must contain a statement informing the reviewer
that signing this document infers that they have read,
understood and agree with the contents of the VSR.
Normally this information is collected on the approval page of
the VSR.

4.3 Introduction
This section is a brief introduction of the product, process,
equipment and/or system that have been validated.
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4.4 Scope
The scope of the VSR must be clearly stated. The business
function that the system addresses and the components of the
system that have been validated through the validation plan
must be identified.

4.5 Definitions
A section providing a glossary of terms used in the document
must be provided.

4.6 References
A section providing a list of document references must be
provided.

4.7 Computer System Description

This section is essentially the same description found in the
Validation Plan and provides a detailed description of the
computer system which has been validated. The section should
be in sufficient detail for all major functions of the system to be
clearly understood. References to other documentation such as
procedures, user operator manuals or technical documents may
be made to indicate detailed functionality. Unique system ID
should also be provided.

4.8 Validation Activity Results

This section includes summaries of all of the DQ IQ, OQ
protocols and other activities described in the appropriate
Validation Plan and which were performed to complete
validation of the computer system. Filenames and titles along
with the final approval dates should be included in the
summaries.
Any critical supporting utilities or services, which had not been
previously listed, should also be described including the
validation status of those systems directly involved with the
process that has been validated. For example, information
related to the ‘source code control’ system used.

4.9 Summary of Failures

This section provides a summary of all deviations to the
Validation Plan encountered while performing the activities of
plan. The deviation should be described as well as the reason,
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corrective actions/investigations taken to resolve the deviation

and/or rationale on why the activity planned was not required.
In addition, final results after the corrective actions were taken
should be discussed. PQ deviations may be listed in this section
if appropriate.

4.10 Conclusion
This section provides the conclusion(s) drawn from the
validation effort. A statement may be written stating that the
process is validated, that all predetermined
specifications/acceptance criteria, etc. have been met, and that
the process is substantially controlled and reproducible. The
validation group signature on the Validation Summary Report
serves to establish that the computer system is validated.