Template Rev 01 Page 1 of 7

Functional Requirements Document Number

Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

Functional Requirements Specification

for
[System/Equipment Name]

1. Remove all blue text from this document before submitting for
approval
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Functional Requirements Document Number
Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

Signature Page

Document Author:
Name (please print) Signature Date

Document Author

Document Approvers:
See the Roles and Responsibilities section of CQA-STD-76, Computer System Validation Standard for
appropriate level of document approvers.
Approver Function Name (please print) Signature Date

Business Owner

System Owner

Quality Assurance
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Functional Requirements Document Number
Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

Table of Contents

1 Purpose and Scope............................................................................................................. 4

2 System Description........................................................................................4
3 References.................................................................................................... 5
4 Definitions and Acronyms...............................................................................5
5 Functional Requirement Specifications............................................................5
5.1 System Security and Controls......................................................................................................... 5
5.2 User Role Administration................................................................................................................. 5
5.3 Automated System/Equipment Alerts.............................................................................................. 6
5.4 System Integration.......................................................................................................................... 6
5.5 Electronic Records and Electronic Signatures................................................................................7
5.6 Audit Trail........................................................................................................................................ 7
5.7 System/Equipment Maintenance.................................................................................................... 7
5.8 Other System/Equipment Functional Requirements.......................................................................8
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Functional Requirements Document Number
Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

1 Purpose and Scope

This section should explain the context of the system within the business process, including:
 Who produced the URS document (e.g., department, function or role), under what authority,
and for what purpose,
 Relationship to other documents (e.g., Business Process Definition, Request for Proposal
(RFP).
This Functional Requirements Specification (FRS) provides a baseline for validation and is
developed to record the required system/equipment functions of the [System/Equipment Name] as it
is intended for use by <insert site name>. This Functional Requirements Specification (FRS)
document contains the uniquely identified criteria for how the [System/Equipment Name] will function
to meet the business and regulatory user requirements

The scope of this FRS is limited to defining the functionality of the [System/Equipment Name] for its
intended use at [insert site name]. Other [System/Equipment Name] features may be added to the
system during future phases of system implementation and validation. Each new requirement of the
system will need to be evaluated to determine its effect on the system’s validated status.

The computerized system validation of the [System/Equipment Name] is to be performed within the
guidelines provided by the C.R. Bard, ‘Computer System Validation Standard (CQA-STD-76) and the
validation approach documented in the approved [System/Equipment Name] Validation Plan
(document number).

2 System Description
A description of the system/equipment providing an overview of the system/equipment should be
provided to explain why the system/equipment is required and what it is required to do, including, but
not limited to:
 Description of the purpose, function and intended use of the computerized
system/equipment,
 Summary of the hardware and software components of the computerized
system/equipment,
 System/equipment data and program inputs and outputs,
 Operator interface to the computerized system/equipment,
 System/Equipment Interfaces to other GxP systems.
The [System/Equipment Name] is (type of system/equipment) developed by/provided by (vendor
name, if applicable). This system/equipment is or is to be implemented at <insert site name> with no
customization of source code.
The [System/Equipment Name] will be used for (specify primary usage) including:
 List specific usage and/or modules


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Functional Requirements Document Number
Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

3 References
Document No. Title
<document number> [System/Equipment Name] Validation Plan

4 Definitions and Acronyms

Acronyms Meaning

5 Functional Requirement Specifications

The Functional Requirements Specification (FRS) document should contain the uniquely identified
criteria for how the computer system or equipment will operate to meet the business and regulatory
user needs. Individual FRS statements shall be traced to the URS (if a URS is required) and
Operational Qualification (OQ) test scripts to ensure that the functional requirements are met and
verified.

The FRS defines clearly, and precisely, how the system or equipment is required to function within its
normal operation range and conditions.

5.1 System Security and Controls

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).
5.1.1 The system will not allow duplication of usernames.
5.1.2 Session timeouts are set to XX minutes.
5.1.3 Password expiration is set to XX days.
5.1.4 Account lockout is set to XX attempts.
5.1.5 Password length is set to XX characters.
5.1.6 System access uses AD for authentication.
5.1.7 The system will allow access remotely through a secure internet portal.
5.1.8 System access requires a valid user name and password.

5.2 User Role Administration

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).
5.2.1 The system administrator will be able to create new users.
5.2.2 The system administrator will be able to create new user groups.
5.2.3 The system administrator will be able to modify user accounts.
5.2.4 The system administrator will be able to modify user groups.
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Functional Requirements Document Number
Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

5.2.5 The system administrator will be able to disable user groups.

5.2.6 The following permission levels will be set up in the system from the security matrix:
5.2.7 System Administrator,
5.2.8 Local Administrator (Super User),
5.2.9 System User (Record Originator, Assign To User),
5.2.10 SME Approver,
5.2.11 Quality Assurance
5.2.12 Responsible Manager,

5.2.13 The System Administrator will have the ability to modify permissions for user accounts
and user groups.
5.2.14 The System Administrator will have the ability to remove permissions for user
accounts and user groups.
5.2.15 The System Administrator will be able to disable user accounts.
5.2.16

5.3 Automated System/Equipment Alerts

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).

5.3.1 The system will have the ability to generate automated alerts to user in the event of
an error condition.
5.3.2 The system will have the ability to send an alert the equipment is out of tolerance
levels.
5.3.3 The system will have the ability to send an alert when an activity is past due.
5.3.4

5.4 System Integration

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).
5.4.1 The system will integrate with the corporate xxxx system (System/Equipment Name)
for (purpose of the integration).
5.4.2 Information from xxxx to yyyy system/equipment will be transferred on a daily basis.
5.4.3 An error log will be generated for any records not transferred successfully.
5.4.4

5.5 Electronic Records and Electronic Signatures

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).
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Functional Requirements Document Number
Specification XXXXXXX-(rev)
System/Equipment (version): Site: <insert site>

5.5.1 The system will be capable of generating accurate and complete copies of electronic
records to both paper and electronic media.
5.5.2 The system will provide for an electronic approval to show that only authorized users
with a unique, valid User ID and password can electronically approve a record.
5.5.3 Electronic approvals will contain:
5.5.4 The printed name of the approver
5.5.5 The date and time when the approval was executed

5.6 Audit Trail

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).
5.6.1 The audit trail will record the following:
5.6.1.1 Record type
5.6.1.2 User name of the person causing the event
5.6.1.3 Date of the event
5.6.1.4 Time of the event
5.6.1.5 Original data
5.6.1.6 New data
5.6.2 The audit trail will not be able to be edited.
5.6.3 The audit trail will not be able to be deleted.
5.6.4

5.7 System/Equipment Maintenance

(The following are examples of FRS statements – please use specific requirements for the
computerized system/equipment being specified).
5.7.1 The system/equipment will be maintained to an approved maintenance schedule.
5.7.2 An alert will be generated by the system/equipment if the scheduled maintenance
activities are past due,
5.7.3 The system will maintain of performed maintenance activities,
5.7.4

5.8 Other System/Equipment Functional Requirements

5.8.1