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Computer System Validation Management Policy Sample

This document provides a standard operating procedure for computer system validation management. It outlines the policy's purpose and scope, defines key terms and acronyms, and describes responsibilities for individuals involved in validation. The procedure section explains the company's validation management approach and outlines the validation process, which includes identifying individuals, performing regulatory impact assessments, developing documentation, and executing validation activities like testing.

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Anton Mymrikov
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© © All Rights Reserved
2K views

Computer System Validation Management Policy Sample

This document provides a standard operating procedure for computer system validation management. It outlines the policy's purpose and scope, defines key terms and acronyms, and describes responsibilities for individuals involved in validation. The procedure section explains the company's validation management approach and outlines the validation process, which includes identifying individuals, performing regulatory impact assessments, developing documentation, and executing validation activities like testing.

Uploaded by

Anton Mymrikov
Copyright
© © All Rights Reserved
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Document No

STANDARD OPERATING PROCEDURE [Document Number]


<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

APPROVALS:
Name Signature Date

REVISION HISTORY:
Revision Initials and Date Summary of Changes
00

Instructions on completing this document


(Please remove this table when you are finished modifying this document.
This table is for your information only.)

- Montrium has inserted instructions in blue text into this document to help you
understand the information in each section. Once you have modified this
document to meet the specifics of your organization, please delete the blue text.

- Blue italicized text in this document indicates elements which should be revised
or completed by you so that the text meets your company’s needs and quality
system requirements. Once you have completed this information, please remove
the italics in the document.

Confidential Page 1 of 34
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

Contents
1.0 PURPOSE .............................................................................................................................. 6
2.0 SCOPE .................................................................................................................................. 6
3.0 DEFINITIONS ........................................................................................................................ 6
3.1 Acronyms ......................................................................................................................... 6
3.1.1 ADR – Adverse Drug Reaction ................................................................................. 6
3.1.2 CDS – Computerized Documentation Service ......................................................... 6
3.1.3 CFR – Code of Federal Regulations ......................................................................... 6
3.1.4 COTS – Commercial Off-the-shelf ............................................................................ 6
3.1.5 CRM – Customer Relationship Management .......................................................... 6
3.1.6 CSV – Computer System Validation ......................................................................... 6
3.1.7 CV – Curriculum Vitae.............................................................................................. 6
3.1.8 DCS – Distributed Control System ........................................................................... 6
3.1.9 DS – Design Specification ........................................................................................ 6
3.1.10 ERP – Enterprise Resource Planning........................................................................ 6
3.1.11 FS – Functional Specification ................................................................................... 6
3.1.12 ID – Identification .................................................................................................... 6
3.1.13 IT – Information Technology ................................................................................... 6
3.1.14 IQ – Installation Qualification .................................................................................. 7
3.1.15 LIMS – Laboratory Information Management System ............................................ 7
3.1.16 MRP – Manufacturing Resource Planning ............................................................... 7
3.1.17 OQ – Operational Qualification ............................................................................... 7
3.1.18 QA – Quality Assurance ........................................................................................... 7
3.1.19 RIA - Regulatory Impact Assessment ....................................................................... 7
3.1.20 RS – Requirement Specification .............................................................................. 7
3.1.21 SCADA – Supervisory Control and Data Acquisition ................................................ 7
3.1.22 SOP – Standard Operating Procedure ..................................................................... 7
3.1.23 UAT – User Acceptance Testing ............................................................................... 7
3.1.24 VNC – Validation Non-Conformance ....................................................................... 7
3.2 Terms ............................................................................................................................... 7
3.2.1 Change Control ........................................................................................................ 7
3.2.2 Computer System .................................................................................................... 7
3.2.3 GxP ........................................................................................................................... 7
3.2.4 Process Owner ......................................................................................................... 7
3.2.5 System Owner ......................................................................................................... 7
3.2.6 Testing ..................................................................................................................... 7
3.2.7 Validation................................................................................................................. 8

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

3.2.8 Validation Team....................................................................................................... 8


3.2.9 Risk........................................................................................................................... 8
4.0 RESPONSIBILITY ................................................................................................................... 8
4.1 IT Manager, representative or designee ......................................................................... 8
4.2 Process Owner(s) ............................................................................................................. 8
4.3 System Owner ................................................................................................................. 8
4.4 QA Representative........................................................................................................... 9
5.0 PROCEDURE ......................................................................................................................... 9
5.1 Computer System Validation Management Approach ................................................... 9
5.2 Computer System Validation Management Process ....................................................... 9
5.2.1 Identify Key Individuals............................................................................................ 9
5.2.2 Perform Regulatory Impact Assessment ............................................................... 10
5.2.3 Identify Requirements ........................................................................................... 10
5.2.4 Plan / Determine Risks and a Strategy for Achieving Compliance ........................ 11
5.2.5 Develop Specifications........................................................................................... 11
5.2.6 Develop Test Methodology, Test Scripts ............................................................... 12
5.2.7 Test and Summarize Results .................................................................................. 12
5.2.8 Training .................................................................................................................. 13
5.2.9 Report and Release................................................................................................ 13
5.2.10 Maintain System Compliance during Operation ................................................... 13
5.3 Computer Systems Validation Management Strategy .................................................. 14
5.3.1 Risk-Based Validation Activities............................................................................. 14
5.3.2 Validation Deliverables per System Category ....................................................... 14
5.3.3 Minimum Content Requirements.......................................................................... 15
5.3.4 Use of Supplier Documentation ............................................................................ 16
5.3.5 Document Approval............................................................................................... 16
6.0 REFERENCES ...................................................................................................................... 16
7.0 List of Appendices.............................................................................................................. 16
Appendix 1: Definition of Categories for Computer Systems ....................................................... 17
Appendix 2: Summary of Validation Management Activities and Deliverables............................ 18
Appendix 3: Computer System Validation Documentation Guide ................................................ 20
7.1 Regulatory Impact Assessment (RIA) ............................................................................ 20
7.1.1 Purpose .................................................................................................................. 20
7.1.2 Minimum Content Requirements.......................................................................... 20
7.2 Requirements Specification (REQ) ................................................................................ 21

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.2.1 Purpose .................................................................................................................. 21


7.2.2 Minimum Content Requirements.......................................................................... 21
7.3 Validation Plan (VPL) ..................................................................................................... 22
7.3.1 Purpose .................................................................................................................. 22
7.4 Risk Assessment (RAA) .................................................................................................. 23
7.4.1 Purpose .................................................................................................................. 23
7.4.2 Minimum Content Requirements.......................................................................... 23
7.5 Functional Specification (FSP) ....................................................................................... 23
7.5.1 Purpose .................................................................................................................. 23
7.5.2 Minimum Content Requirements.......................................................................... 23
7.6 Design Specification (DSP) ............................................................................................. 24
7.6.1 Purpose .................................................................................................................. 24
7.6.2 Minimum Content Requirements.......................................................................... 24
7.7 Configuration Specification (CSP) .................................................................................. 24
7.7.1 Purpose .................................................................................................................. 24
7.7.2 Minimum Content Requirements.......................................................................... 24
7.8 System Description ........................................................................................................ 24
7.8.1 Purpose .................................................................................................................. 24
7.8.2 Minimum Content Requirements.......................................................................... 24
7.9 Validation Protocol ........................................................................................................ 25
7.9.1 Purpose .................................................................................................................. 25
7.9.2 Minimum Content Requirements.......................................................................... 25
7.10 Verification Test Scripts (General) ................................................................................. 26
7.10.1 Purpose .................................................................................................................. 26
7.10.2 Minimum Content Requirements.......................................................................... 26
7.10.3 Types of Verifications ............................................................................................ 26
7.11 Test Summary Report(s) ................................................................................................ 29
7.11.1 Purpose .................................................................................................................. 29
7.11.2 Minimum Content Requirements.......................................................................... 29
7.12 Requirements Traceability Matrix (RTM) ...................................................................... 30
7.12.1 Purpose .................................................................................................................. 30
7.12.2 Minimum Content Requirements.......................................................................... 30

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.13 Validation Summary Report .......................................................................................... 31


7.13.1 Purpose .................................................................................................................. 31
7.13.2 Minimum Content Requirements.......................................................................... 31
7.14 System Release Memo .................................................................................................. 33
7.14.1 Purpose .................................................................................................................. 33
7.14.2 Minimum Content Requirements.......................................................................... 33
Appendix 4: Summary of Validation Deliverables & Designated Approvers................................. 34

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

1.0 PURPOSE
The purpose of this policy is to describe the management of the validation of computer systems
at Company Name.

This policy describes the activities, deliverables and individuals required to achieve and maintain
computer systems in a validated state and in compliance with applicable GxP regulations.

This policy also outlines the minimum content requirements for deliverables produced at each
phase of the computer system validation process.

2.0 SCOPE
This policy applies to all computer systems used to perform or to support GxP-related activities.
All computer system components (including hardware, firmware, installed devices, software
applications, interfaces and networks) that are involved in GxP related activities fall within the
scope of this policy.

Applications not requiring validation include, but are not limited to, the following.
• Common desktop applications
• Applications solely used for progress and planning activities
• Financial systems
• Operating Systems (e.g. Windows, Unix)

3.0 DEFINITIONS
3.1 Acronyms
3.1.1 ADR – Adverse Drug Reaction
3.1.2 CDS – Computerized Documentation Service
3.1.3 CFR – Code of Federal Regulations
3.1.4 COTS – Commercial Off-the-shelf
3.1.5 CRM – Customer Relationship Management
3.1.6 CSV – Computer System Validation
3.1.7 CV – Curriculum Vitae
3.1.8 DCS – Distributed Control System
3.1.9 DS – Design Specification
3.1.10 ERP – Enterprise Resource Planning
3.1.11 FS – Functional Specification
3.1.12 ID – Identification
3.1.13 IT – Information Technology

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

3.1.14 IQ – Installation Qualification


3.1.15 LIMS – Laboratory Information Management System
3.1.16 MRP – Manufacturing Resource Planning
3.1.17 OQ – Operational Qualification
3.1.18 QA – Quality Assurance
3.1.19 RIA - Regulatory Impact Assessment
3.1.20 RS – Requirement Specification
3.1.21 SCADA – Supervisory Control and Data Acquisition
3.1.22 SOP – Standard Operating Procedure
3.1.23 UAT – User Acceptance Testing
3.1.24 VNC – Validation Non-Conformance

3.2 Terms
3.2.1 Change Control

3.2.2 Computer System

3.2.3 GxP

3.2.4 Process Owner

3.2.5 System Owner

3.2.6 Testing

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

3.2.7 Validation

3.2.8 Validation Team

3.2.9 Risk

4.0 RESPONSIBILITY
4.1 IT Manager, representative or designee

4.2 Process Owner(s)

4.3 System Owner

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STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

4.4 QA Representative

5.0 PROCEDURE
5.1 Computer System Validation Management Approach

5.2 Computer System Validation Management Process

5.2.1 Identify Key Individuals

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.2.2 Perform Regulatory Impact Assessment

5.2.3 Identify Requirements

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STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.2.4 Plan / Determine Risks and a Strategy for Achieving Compliance

5.2.5 Develop Specifications

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.2.6 Develop Test Methodology, Test Scripts

5.2.7 Test and Summarize Results

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.2.8 Training

5.2.9 Report and Release

5.2.10 Maintain System Compliance during Operation


5.2.10.1 Change Control

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.2.10.2 System Maintenance

5.2.10.3 System Access

5.2.10.4 On-Going Training

5.2.10.5 Configuration Management

5.3 Computer Systems Validation Management Strategy


5.3.1 Risk-Based Validation Activities

5.3.2 Validation Deliverables per System Category

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.3.3 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

5.3.4 Use of Supplier Documentation

5.3.5 Document Approval


.

6.0 REFERENCES
Document Number Document Title

7.0 List of Appendices


Appendix Number Document Title

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

Appendix 1: Definition of Categories for Computer Systems

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

Appendix 2: Summary of Validation Management Activities and Deliverables

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

Appendix 3: Computer System Validation Documentation Guide

7.1 Regulatory Impact Assessment (RIA)


7.1.1 Purpose

7.1.2 Minimum Content Requirements


•

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.2 Requirements Specification (REQ)


7.2.1 Purpose

7.2.2 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.3 Validation Plan (VPL)


7.3.1 Purpose

7.3.1.1 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.4 Risk Assessment (RAA)


7.4.1 Purpose

7.4.2 Minimum Content Requirements

7.5 Functional Specification (FSP)


7.5.1 Purpose

7.5.2 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.6 Design Specification (DSP)


7.6.1 Purpose

7.6.2 Minimum Content Requirements

7.7 Configuration Specification (CSP)


7.7.1 Purpose

7.7.2 Minimum Content Requirements

7.8 System Description


7.8.1 Purpose

7.8.2 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.9 Validation Protocol


7.9.1 Purpose

7.9.2 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.10 Verification Test Scripts (General)


7.10.1 Purpose

7.10.2 Minimum Content Requirements

7.10.3 Types of Verifications

7.10.3.1 Installation verification


7.10.3.1.1 Purpose

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.10.3.2 Configuration Verification

7.10.3.3 Unit / Integration Verification

7.10.3.4 Operational/Functional Verification

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.10.3.5 Performance/User Acceptance Verification

7.10.3.6 Documentation Verification

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.11 Test Summary Report(s)


7.11.1 Purpose

7.11.2 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.12 Requirements Traceability Matrix (RTM)


7.12.1 Purpose

7.12.2 Minimum Content Requirements

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.13 Validation Summary Report


7.13.1 Purpose

7.13.2 Minimum Content Requirements

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STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

7.14 System Release Memo


7.14.1 Purpose

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Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Computer System Validation Management Policy [Effective Date]

Appendix 4: Summary of Validation Deliverables & Designated Approvers

Designated Approvers
Deliverable
System Process
QA
Owner Owner

Legend: √ Required

Confidential Page 34 of 34

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