Sei sulla pagina 1di 28

Page 1 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

USER REQUIREMENTS SPECIFICATION


CAPA MANAGEMENT SYSTEM

Questo documento è un Template; include le istruzioni e una serie di esempi da tener presente per il
completamento dei contenuti.
E’ stato redatto a partire dal Template di User Requirements Specification proposto da GAMP5 e da
documenti sviluppati dal Gruppo Equipment Validation di ISPE Gamp Forum Italia e dal Gruppo LIMS di
AFI & ISPE Gamp Forum Italia.
Può / Deve essere modificato per adeguamento agli standard aziendali (formato, struttura).

Azienda / Ruolo Nome Cognome Firma Data


Stesura
<Business User> <Name>

<IT Dept> <Name>


Revisione
<Computer System
<Name>
Validation>
<Quality Assurance> <Name>
Approvazione
<System Owner> <Name>
<Quality Assurance
<Name>
Manager>
Completare e adattare la tabella con tutti ruoli coinvolti nel processo di stesura, revisione e
approvazione del documento.
Page 2 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Table of Contents
1 INTRODUCTION...............................................................................................................................4
1.1 PURPOSE..........................................................................................................................................4
1.2 CONTRACTUAL STATUS.....................................................................................................................4
1.3 LIMITATIONS....................................................................................................................................5
1.4 RELATIONSHIP TO OTHER DOCUMENTS.............................................................................................5
1.5 TERMS.............................................................................................................................................5
2 OVERVIEW.........................................................................................................................................6
2.1 PROJECT OVERVIEW.........................................................................................................................6
2.2 KEY OBJECTIVES AND BENEFITS........................................................................................................6
2.3 MAIN FUNCTIONS AND INTERFACES..................................................................................................7
2.4 APPLICABLE REGULATIONS AND STANDARDS.....................................................................................7
3 REQUIREMENT OVERVIEW..........................................................................................................9
4 OPERATIONAL REQUIREMENTS..............................................................................................12
4.1 FUNCTION REQUIREMENTS.............................................................................................................12
4.2 DATA REQUIREMENTS....................................................................................................................13
4.3 TECHNICAL REQUIREMENTS............................................................................................................15
4.4 INTERFACE REQUIREMENTS............................................................................................................15
4.5 ENVIRONMENT REQUIREMENTS.......................................................................................................16
5 CONSTRAINTS................................................................................................................................18
5.1 MILESTONES AND TIMELINES.........................................................................................................18
5.2 AVAILABILITY.................................................................................................................................19
5.3 PROCEDURAL CONSTRAINTS...........................................................................................................20
5.4 MAINTENANCE................................................................................................................................20
6 LIFE-CYCLE......................................................................................................................................21
6.1 DEVELOPMENT................................................................................................................................21
6.2 TESTING........................................................................................................................................23
6.3 DELIVERY.......................................................................................................................................24
6.4 SUPPORT........................................................................................................................................26
7 GLOSSARY........................................................................................................................................27
8 ATTACHMENTS...................................................................................................................................28
Page 3 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Revisioni del Template


Questo paragrafo riguarda le revisione del presente Template. Deve essere cancellato nel nuovo
documento generato a partire da questo Template.

Rev. Data Appr. Scritto da: Revisionato Approvato da: Storia dei cambiamenti
da:
0 AFI - GAMP AFI - GAMP AFI - GAMP
EDPM: EDPM: EDPM Coordinator
(B.Testoni)

Revisioni del Documento


Rev. Data Appr. Scritto da: Revisionato Approvato da: Storia dei cambiamenti
da:
0 - - --- - Prima Emissione
Page 4 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

1 INTRODUCTION
Da URS GAMP:
“The introduction will provide information on:
- who produced the document, under what authority, and for what purpose
- the contractual status of the document (if applicable), e.g.,
- custom development
- outsourcing
- relationship to other documents (e.g., Business Process Definition, Request for Proposal (RFP))”

The URS is a document that has the purpose to define what the system is expected to perform and is
the basis for the design and verification phases of the equipment.
This document should be provided starting from the request for quotation and however it must be
provided in a final version when the contract is defined.
The URS must be maintained up-to-date for the overall equipment development life-cycle as it is the
input for the subsequent phases.

This document was generated under the authority of the <Company for the purpose of specifying the
user requirements for a CAPA management.
Sections 1 and 2 of this document are only explanatory and are not intended to be object of
a qualification activity at later stages of the equipment delivery.
Only uniquely coded requirements of section 3 will be object of a qualification activities.

1.1 Purpose
The User Requirements Specification (URS) is provided to aid the user through the important
components, variables and options necessary to provide a system that meets the user’s needs in the
most cost-effective method possible.
The URS is then provided to the Supplier as an input for the quotation, design, construction,
commissioning and validation of the system.

1.2 Contractual status


This URS will be recognized as an integral part of the procurement agreement with the selected system
vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this
document as well as the standard purchasing term and conditions of the <Company.

BT: Valutare se inserire par. Responsabilità (stesura Documento) e Campo di Applicazione


Page 5 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

1.3 Limitations
Insert possible limitations to the use of the document.
Example: URS are confidential and property of the <Company. The use, the copy and the distribution of
the document are not permitted.

1.4 Relationship to other documents


The present URS can be complemented with other documents such as specific URS for computerized
systems (e.g. EDMS, ERP).
INSERT HERE THE REFERENCE TO THE IDENTIFIED DOCUMENT

1.5 Terms
Verify and integrate the definition of terms used in the document and their meaning.
Insert possible further indications the help the proper interpretation of the document.
Where statements in the specification include the words “must”, “shall”, "is to" or “will”, it indicates that
compliance with the item is regarded as mandatory. Where such recommendations cannot be
implemented, the Supplier must notify the User.
Where the word “should” or “may” is used, the statement is a recommendation for guidance and
adoption as good practice. It is accepted that an alternative may be more appropriate, however
consultation with User is still required.
Page 6 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

2 OVERVIEW
Da URS GAMP:
“An overview of the system will be provided, explaining why it is required, and what is required of the
system. The following will be considered:
 background: describes the overall goal of the system in context of the present and
desired state
 scope:
- what portion of the long-term vision the current system will address
- system limits and boundaries: what business process or portion of a business process is being
automated
- key objectives and benefits
- applicable GxP requirements
- other applicable regulations

Provide a high level general description of the system in order to anticipate the detailed requirements
that will be included in the following sections.
This paragraph does not have to contain specific requirements.

2.1 Project overview


The system is used to manage the information relevant to the CAPA’s activities.
This system will be installed in the <Site Plant and it will be operated according to <Company
procedures.
The performances and objectives to be obtained will be detailed later on in the document.
It is possible to indicate the reason why the system will be purchased:
 improvement of the activities
 substitution of obsolete system
 others

2.2 Key objectives and benefits


Indicate the wished key objectives and benefits and ensure that these benefits are covered by the
specific requirements included in section 3 and satisfied using indexes/percentages of improvement.
Example: 5% of improvement of CAPA process efficiency.
The project has the following key objectives and benefits:
List the key objectives and benefits:
Page 7 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

 Improve activities efficacy


 Improve activities efficiency

2.3 Main functions and interfaces


Verify contents, leaving applicable functions and interfaces.
The system provides the following main functions:
 (...)
 Other functions (specify)

The system provides the following main logical interfaces:


 Data exchange with ERP systems
 Data exchange with EDMS systems
 Other logical interfaces (specify)

2.4 Applicable regulations and standards


This paragraph has only the purpose to list the references to the regulations and standards that are
applicable to the supply. Related detailed requirements will have to be specified in the following
sections.
It's fundamental to define roles and responsibilities for user and supplier in case of specific
pharmaceutical regulations (GxP). The supplier must satisfy specific requirement formulated by the user.
The user is responsible for the proper application of the regulation to the system and to the process in
which the equipment is integrated.
This section briefly identifies the regulations and standards that are applicable to the equipment that
Supplier should consider during the development life-cycle. The expectations regarding each regulation
and standard will be detailed later on in the document.

2.4.1 Regulatory requirements


Verify the contents. Remove or add the reference regulations.
The following regulations should be considered during the development of the equipment:
 21 CFR Part 210 / 211 (specify applicable sub-sections)
 European GxP (specify applicable sub-sections)
 21 CFR Part 11
 EU Annex 11
 INSERIRE x CAPA
 Add other regulations.
 Other regulations (specify)
Page 8 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

2.4.2 Company Standards


Verify the contents. Add any customer’s internal standards that have to be used as reference for the
project.
The following company internal standards or guidelines should be considered during the implementation
of the system:
 Specify internal standards (if applicable)

2.4.3 Other reference documents


Verify the contents. Add or remove reference standards.
The following standards or guidelines should be considered during the development of the equipment:
 GAMP 5 “A Risk-Based Approach to Compliant GxP Computerized Systems – 2008”

 Other guidelines (specify)
Page 9 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

3 REQUIREMENT OVERVIEW
Before the list of requirements, it is important to define the single requirement structure, taking into
consideration the need for traceability of the requirements.
Each requirement should have:
1. An unambiguous unique code.
The coding used for this document is:
<REQTYPE>.<REQCATEGORY>###
Requirement type:
UR – Operational Requirement
UC – Constraints
UL – Life Cycle
Category examples for Operational Requirement:
F – Function
I – Interface
D – Data
etc.
Examples of complete codes:
UR.F001 - Function
UC.M001 - Maintenance
UL.P001 – Project Documentation
2. A title.
3. A detailed description with possible related tables or pictures.
4. An indication of the obligatory level of the requirement (Must or Desirable).
All GxP requirements should be MUST.
5. An indication of the criticality level of the requirement (type and impact size)
On Table 1 we supply the description of scenarios for the classes and for the levels used in order to
assign such values to each requirement.

Moreover, a requirement can be structured in a hierarchy of sub-requirements (sons) in order to detail


some aspects of the general one (father). In this case, in order to guarantee the traceability from the
father, a son requirement will have a code derived from the father’s one obtained by adding a
progressive number to the father’s code.

Keep in mind that, in order to guarantee the traceability of requirements, it is necessary that each
requirement is classified and classifiable. It must be avoided, therefore, the union of several real
requirements in a single requirement in the document. It must be avoided, moreover, the use of
point/number lists for details of a single requirement.
It must also be avoided the duplication of requirements: the same requirement in various points of the
document and even with different descriptions.
Page 10 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

In case of new revisions of the document, in order to maintain the traceability and to make easy the
impact analysis of the new version on the project, it is important to highlight all changes with a visual
indication regarding the status of the requirement.
Following rules should be applied:
6. It must be avoided the re-use of removed codes. It should be given the evidence of the fact that a
particular code has been removed (indicating it with the appropriate style: crossed)
7. It should be given the evidence of the fact that a requirement had been modified or added (during
the last revision), indicating it with the appropriate style (Modified  Bold Style, New  Underlined)
.
Moreover, on the Document Change History there should be a detailed list requirements that had
been added, removed and modified.
The following sections include detailed requirements that will be subject to testing.

The detailed requirements are divided in the following sections:


 Operational
 Constraints
 Life-cycle

Each operational requirement is identified with the following information:


 Code: unique code of the UR (traceable to Test Verification and Supplier Documentation)
 Title and Description: brief title identifying the requirement followed by the text of the specific
requirement to be satisfied
 Mandatory level
 M: Must
 D: Desirable
 Criticality class
This information should be used by User to define the validation approach in the Validation Plan.
 GxP: relevant to quality
 Business: relevant to business risk (e.g.: machine efficiency)
 Criticality level
This data is fully applicable for GxP and Safety criticality classes. For business class requirements the
level indication can be marked as N/A.
Refer to Table 1 for details.
 H: high impact
 M: medium impact
 L: low impact

Constraint and Life-cycle requirements are identified with a unique code for traceability purpose.

Specific tables can be used as a reference by any requirements.


Page 11 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Table 1 – Criticality scenarios


Following table provides the description of the different criticality scenarios for each criticality class.
For each class and for each level (High, Medium, Low) an applicable scenario must be defined.
The content of this table must be considered as an example. It must be verified and adapted to the
specific application.

GxP Criticality Class


Specify scenarios using as reference risks listed on GAMP5 Appendix M3
Level Scenario
H Major or irreversible side-effects on the patient (e.g. defects seriously impacting the
efficacy, purity of the product), and/or critical defects on the product aspect.
M Modest and reversible side-effects on the patient (e.g. defects impacting the efficacy,
purity of the product), and/or significant defects on the product aspect.
L Minor or negligible side-effects on the patient and/or aesthetical defects on the
product aspect.

Business Criticality Class


Specify scenarios using as reference risks listed on GAMP5 Appendix M3
Level Scenario
H Production break with loss of the production batch in progress and/or high time/costs
for intervention (system stopped).
M Production break without loss of the batch in progress (possible need of rework)
and/or medium time/costs for intervention (system stopped).
L Temporary production break with negligible time/costs for intervention.
Page 12 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

4 OPERATIONAL REQUIREMENTS

Da URS GAMP:
“Operational requirements include:
 functions
 data
 technical requirements
 interfaces
 environment
Process descriptions or flowcharts may be included as appropriate.
Special consideration will be given to critical GxP requirements. These will be clearly defined, with
references to the relevant regulation, where possible.
All requirements will be verifiable.
It will be noted that some requirements may be difficult to define and verify because they are subjective
and therefore may be subject to different interpretation. The measurement or acceptance criteria for
these requirements will be specifically defined as part of the approved requirement.”

The following tables include several requirement examples. The criticality level for the GxP and Business
classes has been inserted only as an example considering an hypothetical application for a life-saver
product.
For business requirements it is admitted to specify N/A as criticality level if no impact on the on-going
operation is identified.
It is therefore recommended to verify each single value assigned to the requirements and adapt them to
the specific application.

4.1 Function Requirements

DA GAMP5:
“Those functional requirements that would enable a system to perform the business process being
automated will be documented. The following will be addressed as appropriate:
Calculations, including all critical algorithms (e.g., those required for compliance with regulations or
internal process requirements). Critical algorithms will be documented with references to their scientific
sources. Algorithms that have been custom developed will be scientifically derived.
 safety
 security including access control
 audit trails
Page 13 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

 use of electronic signatures


 output (e.g., reports. files)
 unambiguous error messages”

Other: layouts, calculations, modes of operations, performance and timing requirements, actions
required in case of failure, safety.

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UR.F001 Title M GxP / L
Description Business

COMPLETE THE TABLE

4.2 Data Requirements

Da URS GAMP5:
“Data handling requirements will be documented. Consideration will be given to understanding the
impact upon patient safety, product quality, and data integrity. The following will be addressed as
appropriate:
 definition of electronic records
 definition of data, including identification of characteristics, formatting, critical parameters, valid
data ranges,
 limits and accuracy, character sets, etc.
 required fields
 data migration
 data input and subsequent editing
 backup and recovery
 archive requirements
 data security and integrity”

Critical parameters, archives, data integrity, access speed requirements, capacity requirements.
Page 14 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Substitute the fields such as <ER Regulation> with the name of the regulation to be applied such as 21
CFR Part 11 or GMP EU Annex 11. The reference should be followed by punctual identification of the
items of the regulation to be satisfied.
Include possible preferential brands for components or specific architectural configurations.

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UR.D001 User Management M GxP M
The system shall provide user management
features according to <ER.
Indicate in detail the items of the regulation
that must be satisfied.
UR.D002 User Profiles and System Access M GxP M
The system shall provide at least N different
user profiles:
The profiles depend on the Customer
organization.
Possibly refer to a specific table with the
detailed description of various profiles.
 ???
 Administrator: full control
UR.D002. Access to system must be limited to authorized
01 individuals.
UR.D002. Automatic authority checks must be in place to
02 access a system or perform operations (e.g.:
each user will access only to functions allowed
to the relevant role).
UR.D003 Data to be recorded M GxP M
The systemwill provide the following data to be
recorded:
Complete the list of critical data to be
recorded.

UR.D004 Audit Trail M GxP M
The esystem shall provide audit trail feature
for the critical electronic records handling
according to <ER.
Indicate in detail the items of the regulation
that must be satisfied.
Page 15 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UR.D005 Process Parameters Retention M GxP M
The system shall be designed to retain the
process parameters in case of power loss, and
be able to recover with minimal operator
actions.
UR.D006 Data Backup M GxP M
The system must automatically perform a
backup of the parameters, production and
configuration data.
UR.D007 Data Backup Export M GxP M
It shall be possible to export data backup in
order to store them into a physical safe
environment (e.g.: Centralized Server).
UR.D008 Data Restore M GxP M
A restore procedure must be available in order
to restore the last data backup.
COMPLETE THE TABLE

4.3 Technical Requirements

Da URS GAMP:
“System technical requirements will be defined. The following will be addressed as appropriate:
 changes in system operation (e.g., start-up, shutdown, test, failover)
 disaster recovery
 Performance and timing requirements. These will be quantitative and unambiguous.
 action required in case of failure
 capacity requirements
 access speed requirements
 hardware requirements
 portability
 efficiency (speed with which it loads, updates screens, generates reports)
 configurability”

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UR.T001 Title M GxP / L
Description Business
Page 16 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Code Requirement Description Mandatory Criticality Criticality


Level Class Level

COMPLETE THE TABLE

4.4 Interface Requirements

Da URS GAMP:
System interfaces will be defined. The following will be addressed as appropriate:
 Interface(s) with users. These will be defined in terms of roles, (e.g., plant operator, warehouse
administrator, system manager) or functions as appropriate.
 Interface(s) with other systems
 Interface(s) with equipment, such as sensors and actuators. This may include I/O listings for
process control systems.”

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UR.I001 Title M GxP / L
Description Business

COMPLETE THE TABLE

4.5 Environment Requirements

Da URS GAMP5:
The environment in which the system is to work will be defined. The following will be addressed as
appropriate:
 layout: the physical layout of the plant or other work place may have an impact on the system,
such as long distance links or space limitations
 physical conditions (e.g., temperature, humidity, external interference, shielding against radio-
frequency, electro-magnetic and/or UV-interference, dirty, dusty, sterile, or high vibration
environment)
 physical security
Page 17 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

 power requirements (e.g., voltage, amperage, filtering, loading, earthing protection,


uninterruptible power supply (UPS))
 any special physical or logical requirements“

Layout and physical conditions.


Add specific requirements regarding Vibration levels, Electromagnetic interference levels, area
classification (e.g.: ATEX), noise levels, etc.

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UR.T001 Title M GxP / L
Description Business
UR.T002 Temperature and Humidity M GxP M
The capsule filler shall be installed in an
environment with a temperature range of <Min
to <Max °Fahrenheit/Celsius and relative
humidity range of <Min to <Max%.
Indicate the unit of measure for temperature
(e.g.: Celsius, Fahrenheit) following Customer
own reference standards.

COMPLETE THE TABLE


Page 18 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

5 CONSTRAINTS
Da URS GAMP:
“The constraints on the specification and operation of the system will be identified. The following will be
addressed as appropriate:
 compatibility, taking into account:
 any existing systems or hardware
 any regulated company strategy or policy
 availability
 reliability requirements
 maximum allowable periods for maintenance or other downtime
 statutory obligations
 working methods
 user skill levels
 expansion capability
 likely enhancements
 expected lifetime
 long term support“

5.1 Milestones and Timelines

This paragraph has the purpose to indicate possible time constraints on the project life-cycle regarding
the milestones such as quotation issue, validation documentation delivery for approval, FAT, delivery,
etc.

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UC.M001 Quotation M Business N/A
The Supplier shall provide a written proposal of
quotation within <No. weeks of receipt of this
document at the Supplier’s local office.
UC.M002 Required Documentation M Business N/A
The Supplier shall provide the required
documentation according to paragraph “Project
Documentation”.
UC.M003 Documentation Review and Approval M Business N/A
The User shall review, comment and/or
approve, and return the documentation to the
Supplier within <No. weeks of receipt from the
Supplier.
Page 19 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UC.M004 System Delivery M Business N/A
The system shall be delivered to the User’s
receiving dock on or before <Delivery.
COMPLETE THE TABLE

5.2 Availability
Code Requirement Description Mandatory Criticality Criticality
Level Class Level
UC.A001 Operation Timing M Business N/A
The system is intended to be operated:
_________ hours per day
_________ days per week

UC.A002 Maintenance Timing M Business N/A


Operation of the system shall be shut down,
and the machine shall be available for
maintenance or service:
_______ hours per week
_______ continuous hours per week
_______ days per month
_______ weeks per year

COMPLETE THE TABLE


Page 20 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

5.3 Procedural Constraints


The Supplier shall adhere to the indicated sections only.

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UC.P001 Design for GMP Compliance M GxP H
The system shall be designed to meet the
appropriate GMP regulations. e.g.: 21 CFR part
210 and 211 as published at the time of order.
UC.P006 In case of update of the reference guideline M GxP M
update also the requirement.
GAMP Methodology
The Supplier shall use the methodology
described in GAMP 5 to produce the
documentation.
OTHER STANDARDS TO BE ATTACHED

5.4 Maintenance
Code Requirement Description Mandatory Criticality Criticality
Level Class Level
UC.M001 Maintenance Scheduling M Business N/A
The system shall be maintained on a schedule
as indicated by the supplier.
UC.M001. Maintenance Instructions M Business N/A
01 Supplier is to provide (at minimum) the
maintenance instructions.

COMPLETE THE TABLE


Page 21 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

6 LIFE-CYCLE

Da URS GAMP:
“Any specific requirements that may impact the supplier's development life cycle and any subsequent
verification activities will be identified. If this information is already provided elsewhere this will not be
repeated.
The following will be addressed as appropriate:
 development requirements, (e.g., minimum standards to be met by supplier's methodology)
 procedures for project management and quality assurance
 mandatory design methods
 special testing requirements
 test data
 load testing
 required simulations
 factory acceptance testing
 how deliverable items are to be identified
 in what form deliverables are to be supplied (e.g., format and media)
 documentation the supplier is expected to deliver (e.g., functional specification, testing
specifications, design specifications, user and maintenance guides or manuals)
 data to be prepared or converted
 tools
 training courses
 archiving facilities
 support and maintenance required after acceptance”

This section contains specific requirements that the Customer communicates to the Supplier and that
potentially are or will be defined in a Validation Plan document.
This approach allows the user to produce the Validation Plan only for internal use. User therefore does
not need to provide that document to the supplier as the really important requirements are included in
the current section.
The Supplier Quality and Project Plan documents are the answer to the requirements of this section.

6.1 Development
Code Requirement Description Mandatory Criticality Criticality
Level Class Level
UL.D001 Quality and Project Plan M GxP M
The Supplier shall provide a Quality and
Project Plan as part of its proposal.
Page 22 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UL.D002 Supplier Quality System M GxP M
The Supplier shall have a quality system in
place. Internal quality procedures shall be
available for the User’s audit.
UL.D003 Supplier Project Management M GxP M
The Supplier shall provide a Project Manager
for the project to provide a single
communication point with the User.
UL.D004 Version Control M GxP M
There shall be a formal version and release
control for all software and documents.
UL.D005 Change Control M GxP M
The Supplier shall have their own System for
Change Control for all changes during this
project.
UL.D006 Changes approval M GxP M
After the acceptance of equipment, all changes
shall be accepted by <Company in advance
and confirmed in writing by both parties.
COMPLETE THE TABLE
Page 23 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

6.2 Testing
Code Requirement Description Mandatory Criticality Criticality
Level Class Level
UL.T001 Supplier Internal Test M GxP M
Prior to the Factory Acceptance Test (FAT),
Supplier shall perform their own tests and
relevant records shall be available for
inspection.
UL.T002 Factory Acceptance Test (FAT) M Business N/A
In order to verify machine performance, the
User shall witness the execution of the
approved Factory Acceptance Test (FAT)
procedures.
UL.T002. The Supplier shall prepare a Factory
01 Acceptance Test Specification that defines
tests, which can be executed outside the
system operating environment, in order to
check congruence of the system to the User
Requirements as defined in URS and its proper
functioning with user’s products.
Indicate possible specific requirements on the
product to be used during testing phase.
Example: usage of Placebo instead of the real
product.
UL.T002. The Supplier shall notify the User <No. weeks
02 in advance of the start of this test.
UL.T002. The FAT specification shall be submitted to the
03 User for review and approval, at least <No.
weeks, prior to execution.
UL.T003 Site Acceptance Test (SAT) M Business N/A
In order to verify machine performance, the
User shall witness the execution of the
approved Site Acceptance Test (SAT)
procedures.
UL.T003. The Supplier shall prepare a Site Acceptance
01 Test Specification that includes tests that
confirm FAT results and check equipment
proper functioning in the operating
environment with final user’s utilities and
products.
Page 24 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UL.T003. The FAT specification shall be submitted to the
02 User for review and approval latest <No.
before delivery to <Company site.
UL.T003. The result of the SAT shall be reported and
03 sent to <Company for approval before IQ
starts.
COMPLETE THE TABLE

6.3 Delivery
6.3.1 Project Documentation

Code Requirement Description Mandatory Criticality Criticality


Level Class Level
UL.P001 Document Traceability M GxP L
Each document shall be uniquely traceable.
UL.P002 Document Version Control M GxP L
Official documents shall be version controlled
UL.P003 Document List M GxP L
A document list, covering all documentation,
included in the delivery (see Table 2), shall be
compiled
UL.P004 Document Delivery Schedule M Business N/A
All documents shall be delivered according to
the project phase listed in Table 2
UL.P005 Document Language M Business N/A
Documents shall be in the language of the
destination country according to the Mandatory
level included in Table 2.
UL.P006 Document Format M Business N/A
Documents shall be supplied in the format
specified in Table 2.
UL.P007 Document Required Copies M Business N/A
The Supplier shall supply 1 copy of Documents
identified in Table 2.
UL.P008 Document Required Copies M Business N/A
The Supplier shall supply <No. additional
copies of Instruction Manual.
COMPLETE THE TABLE
Page 25 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

Complete the table including further general requirements regarding the Documentation or detailed
requirements on specific documents (e.g.: for a Traceability Matrix it is important to indicate which
documents should be traced).

Table 2 – Document List

Complete the following table including the required documentation, indicating in the column “User
Language (Mandatory Level)” if a translation of the document in the language of the destination country
(M-Mandatory; O-Optional; NA-Not Applicable) is required and indicating the format of the document
required (doc, pdf, dxf, paper, …) in the column “Format”. Specific requirements regarding the
documentation should however be defined in the requirement table of the section “Project
Documentation”.

level)User Language (Mandatory


Project Stage

System Design
With Quote

Before FAT

For IQ/OQ
Code Document Format

D003 Project and quality plan ? ? 


D004 Project schedule and milestones ? ? 
D005 Functional Specification ? ?  
D006 Software Design Specification ? ?  
D007 Hardware Design Specification ? ?  
D008 Installation Qualification ? ?  
D009 Operational Qualification ? ?  
D011 Instruction Manual (operator, maintenance and service) ? ? 
D017 Backup copy of software (e.g.: CD-ROM, memory card) ? ? 
COMPLETE THE TABLE
Page 26 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

6.4 Support
Code Requirement Description Mandatory Criticality Criticality
Level Class Level
UL.S001 Start-up Support M Business N/A
Start-up support shall consist of <No. weeks
of full time assistance on the User’s site for
installation, start-up and commissioning.
UL.S002 Qualification Activities M Business N/A
Supplier shall provide technicians for
supporting User in Qualification Activities for
<No. weeks.
UL.S003 Training M GxP M
User training shall consist of <No. hours of
Operator training and <No. hours of
Maintenance training
UL.S003. The Supplier shall after performed training
01 deliver certificate of performed training.
UL.S003. The supplier shall provide training
02 documentation during the training.
UL.S004 Technical Support M Business N/A
Technical support shall be provided via
telephone for a period of <No. years following
the completion of commissioning.
COMPLETE THE TABLE
Page 27 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

7 GLOSSARY
Acronym Definition
CFR Code of Federal Regulations
DS Design Specification
FS Functional Specifications
GAMP Good Automated Manufacturing Practice
GMP Good Manufacturing Practice
HMI Human Machine Interface
IQ Installation Qualification
OQ Operational Qualification
OSHA Occupational Safety and Health Administration
PLC Programmable Logic Controller
PQ Performance Qualification
SOP Standard Operating Procedure
TM Traceability Matrix
URS User Requirements Specification
VP Validation Plan
Page 28 of 28

USER REQUIREMENTS SPECIFICATION Cod. Doc.: XXX-YYY


CAPA MANAGEMENT SYSTEM Edizione: 0

8 ATTACHMENTS
Insert in the table references to documents attached to the current URS.

Code Document
ANNEX001
ANNEX002
ANNEX003