Computer System Validation Management Policy Sample

STANDARD OPERATING PROCEDURE TITLE Computer System Validation Management Policy

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Contents 1.0

PURPOSE PURPOS E ................................... ................. .................................... ................................... ................................... .................................... ................................... .................... ... 6

2.0

SCOPE ................................. ............... .................................... .................................... ................................... ................................... .................................... .......................... ........ 6

3.0

DEFINITIONS DEFINI TIONS ................................... ................. .................................... ................................... ................................... .................................... ................................ .............. 6

3.1

Acronyms Acron yms ................................. ............... .................................... ................................... ................................... .................................... ................................... ................. 6

3.1.1

ADR – Adverse Advers e Drug Reaction React ion .................................. ................. ................................... .................................... ............................. ........... 6

3.1.2

CDS – Computerized Documentation Service .................. ........................... .................. .................. .................. ............ ... 6

3.1.3

CFR – Code of Federal Regulations ................. .......................... .................. .................. .................. ................... ................... ........... 6

3.1.4

COTS – Commercial Commer cial Off-the-shelf 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 Curric ulum Vitae .................................. ................ .................................... ................................... ................................... ......................... ....... 6

3.1.8

DCS – Distributed Control System ................. .......................... .................. .................. .................. ................... ................... ............ ... 6

3.1.9

DS – Design Specificatio Speci fication n .................................. ................. ................................... .................................... ................................... ................... 6

3.1.10

ERP – Enterprise Resource Planning Planning................... ............................ .................. .................. .................. .................. ................. ........ 6

3.1.11

FS – Functional Functi onal Specification Specif ication ................................... .................. ................................... .................................... .............................. ............ 6

3.1.12

ID – Identification Identif ication ................................... ................. ................................... ................................... .................................... .............................. ............ 6

3.1.13

IT – Information Inform ation Technology Techno logy .................................... .................. ................................... ................................... .............................. ............ 6

3.1.14

IQ – Installation Instal lation Qualification Qualific ation ................................... ................. .................................... ................................... ............................. ............ 7

3.1.15

LIMS – Laboratory Information Management System ................. .......................... .................. .................. ......... 7

3.1.16

MRP – Manufacturing Resource Planning .................. ........................... .................. .................. .................. .................. ......... 7

3.1.17

OQ – Operational Operat ional Qualification Qualific ation .................................... .................. ................................... ................................... .......................... ........ 7

3.1.18

QA – Quality Assurance Assuranc e ................................. ............... .................................... ................................... ................................... ....................... ..... 7

3.1.19

RIA - Regulatory Impact Assessment Assessment .................. ........................... .................. .................. .................. ................... ................. ....... 7

3.1.20

RS – Requirement Require ment Specification Specifi cation ................................... .................. ................................... .................................... ......................... ....... 7

3.1.21

SCADA – Supervisory Control and Data Acquisition Acquisition .................. ........................... .................. ................... ............ .. 7

3.1.22

SOP – Standard Operating Procedure .................. ........................... .................. .................. .................. .................. ............... ...... 7

3.1.23

UAT – User Acceptance Testing................. ........................... ................... .................. .................. .................. .................. ................ ....... 7

3.1.24

VNC – Validation Validat ion Non-Conformance Non-Confo rmance ................................. ................ ................................... .................................... .................... .. 7

3.2

Terms ................................. ................ ................................... .................................... ................................... ................................... .................................... ....................... ..... 7

3.2.1

Change Control Contro l .................................. ................ .................................... ................................... ................................... ................................... ................. 7

3.2.2

Computer Compute r System ................................. ............... .................................... ................................... ................................... ................................ .............. 7

3.2.3

GxP

7

















3.2.8

Validation Validat ion Team ................................... .................. ................................... .................................... ................................... ................................ ............... 8

3.2.9

Risk ................................... ................. ................................... ................................... .................................... ................................... ................................... .................. 8

4.0

RESPONSIBIL RESPON SIBILITY ITY .................................... .................. ................................... ................................... .................................... ................................... .......................... ......... 8

4.1

IT Manager, representative or designee .................. ........................... .................. .................. .................. .................. .................. ........... 8

4.2

Process Proce ss Owner(s) Owner( s) .................................... .................. ................................... ................................... .................................... ................................... .................... ... 8

4.3

System Syste m Owner .................................. ................ .................................... ................................... ................................... .................................... .......................... ........ 8

4.4

QA Representat Repre sentative.......... ive............................ .................................... ................................... ................................... .................................... .......................... ........ 9

5.0

PROCEDURE PROCED URE ................................. ................ ................................... .................................... ................................... ................................... ................................... ................. 9

5.1

Computer System Validation Management Approach .................. ........................... .................. .................. ............... ...... 9

5.2

Computer System Validation Management Process ................. .......................... ................... ................... .................. ........... 9

5.2.1

Identify Identi fy Key Individuals.............. Individu als............................... ................................... .................................... ................................... ......................... ........ 9

5.2.2

Perform Regulatory Impact Assessment .................. ........................... .................. .................. .................. .................. ......... 10

5.2.3

Identify Identi fy Requirements Require ments ................................... .................. ................................... .................................... ................................... .................... ... 10

5.2.4

Plan / Determine Risks and a Strategy for Achieving Compliance .................. ........................ ...... 11

5.2.5

Develop Develo p Specification Specif ications.................. s................................... ................................... .................................... ................................... .................... ... 11

5.2.6

Develop Test Methodology, Test Scripts .................. ........................... .................. .................. .................. .................. ......... 12

5.2.7

Test and Summarize Summar ize Results .................................... .................. ................................... ................................... ............................. ........... 12

5.2.8

Training ................................... .................. ................................... .................................... ................................... ................................... .......................... ........ 13

5.2.9

Report and Release.............. Releas e................................ .................................... ................................... ................................... ............................. ........... 13

5.2.10

Maintain System Compliance during Operation .................. ........................... .................. .................. ............... ...... 13

5.3

Computer Systems Validation Management Strategy ................... ............................ .................. .................. ............. .... 14

5.3.1

Risk-Based Risk-Ba sed Validation Validatio n Activities Activit ies .................................. ................ ................................... ................................... .......................... ........ 14

5.3.2

Validation Deliverables per System Category ................. ........................... ................... .................. .................. ........... 14

5.3.3

Minimum Content Conten t Requirements. Require ments................... .................................... ................................... ................................... .................... .. 15

5.3.4

Use of Supplier Supplie r Documentation Docume ntation .................................... .................. ................................... ................................... ....................... ..... 16

5.3.5

Document Docume nt Approval .................................. ................. ................................... .................................... ................................... ......................... ........ 16

6.0

REFERENCES REFERE NCES .................................. ................ ................................... ................................... .................................... ................................... ............................... .............. 16

7.0

List of Appendices Appendic es.................................. ................. ................................... .................................... .................................... ................................... ...................... ..... 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 20 7.1

Regulatory Impact Assessment (RIA)

20

















7.2.1

Purpose .................................. ................ .................................... ................................... ................................... .................................... ........................... ......... 21

7.2.2

Minimum Content Requirements.................. Requirements........................... .................. .................. .................. .................. .................. ........... .. 21

7.3

Validation Validat ion Plan (VPL) .................................... .................. ................................... ................................... .................................... .............................. ............ 22

7.3.1 7.4

Purpose .................................. ................ .................................... ................................... ................................... .................................... ........................... ......... 22 Risk Assessment Assessm ent (RAA) ................................. ............... .................................... ................................... ................................... .............................. ............ 23

7.4.1

Purpose ................................... ................. ................................... ................................... .................................... ................................... .......................... ......... 23

7.4.2

Minimum Content Requirements................. Requirements.......................... .................. .................. .................. ................... ................... ........... .. 23

7.5

Functional Functio nal Specificatio Speci fication n (FSP) .................................. ................ .................................... ................................... ................................... .................. 23

7.5.1

Purpose ................................... ................. ................................... ................................... .................................... .................................... .......................... ........ 23

7.5.2

Minimum Content Requirements................. Requirements.......................... .................. .................. .................. .................. ................... ............ .. 23

7.6

Design Specification Speci fication (DSP) .................................. ................. ................................... .................................... .................................... ....................... ..... 24

7.6.1

Purpose ................................... ................. .................................... ................................... ................................... .................................... .......................... ........ 24

7.6.2

Minimum Content Conten t Requirements. Requir ements................... ................................... ................................... .................................... .................... .. 24

7.7

Configuration Configu ration Specification Specifi cation (CSP) ................................... .................. ................................... .................................... ............................. ........... 24

7.7.1

Purpose ................................... .................. ................................... .................................... ................................... ................................... .......................... ........ 24

7.7.2


7.8

System Description Descr iption .................................. ................ .................................... .................................... ................................... .................................. ................. 24

7.8.1

Purpose .................................... .................. ................................... ................................... .................................... ................................... ......................... ........ 24

7.8.2


7.9

Validation Validati on Protocol Proto col .................................. ................. ................................... .................................... ................................... .................................. ................. 25

7.9.1

Purpose .................................... .................. ................................... ................................... .................................... .................................... ......................... ....... 25

7.9.2

Minimum Content Conten t Requirements.. Require ments................... ................................... .................................... ................................... ................... .. 25

7.10

Verification Test Scripts (General) ................. .......................... ................... ................... .................. .................. .................. .................. ......... 26

7.10.1

Purpose ................................. ................ ................................... .................................... ................................... ................................... ............................ .......... 26

7.10.2


7.10.3

Types of Verifications Verific ations ................................... ................. .................................... ................................... ................................... ...................... .... 26

7.11

Test Summary Report(s) Repor t(s) ................................. ............... .................................... ................................... ................................... ............................ .......... 29

7.11.1

Purpose .................................. ................ ................................... ................................... .................................... ................................... ........................... .......... 29

7.11.2

Minimum Content Requirements.........

29
















7.13


Validation Validat ion Summary Report ................................. ................ ................................... .................................... ................................... ..................... .... 31

7.13.1

Purpose .................................. ................ .................................... ................................... ................................... .................................... ........................... ......... 31

7.13.2


7.14

System Syste m Release Memo .................................... .................. ................................... ................................... .................................... ........................... ......... 33

7.14.1 7.14 .1

Purpose .................................. ................ .................................... ................................... ................................... .................................... ........................... ......... 33

7.14.2

Minimum Content Requirements................. Requirements.......................... ................... ................... .................. .................. .................. ........... .. 33

Appendix 4: Summary of Validation Deliverables & Designated Approvers................. .......................... ................ ....... 34

















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 of Federal Regulations

3.1.4

COTS – Commercial C ommercial 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


















3.1.14 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

















3.2.7

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)

















4.4

QA Representative

5.0 PROCEDURE 5.1

Computer System Validation Management Approach

















5.2.2

Perform Regulatory Impact Assessment

















5.2.4

Plan / Determine Risks and a Strategy for Achieving Compliance



















5.2.6

Develop Test Methodology, Test Scripts

















5.2.8

Training

















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

































5.3.4

Use of Supplier Documentation

5.3.5

Document Approval


.

6.0 REFERENCES Document Number

Document Title


















Appendix 1: Definition of Categories for Computer Systems

















Appendix 2: Summary of Validation Management Activities and Deliverables

Document No [Document Number ] Revision: [00] Effective date [Effective Date ]
















Document No [Document Number ] Revision: [00] Effective date [Effective Date ]
















Appendix 3: Computer System Validation Documentation Guide

7.1 7.1.1

Regulatory Impact Assessment (RIA) Purpose

















7.2 7.2.1

Requirements Specification (REQ) Purpose



















7.3

Validation Plan (VPL)

















7.4

Risk Assessment (RAA)

















7.6

Design Specification (DSP)

















7.9

Validation Protocol

















7.10 Verification Test Scripts (General)






































































































Computer System Validation Management Policy Sample

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