GAMP 5 Guide A Risk Based Approach to Compliant GxP Computerized Systems 2nd edition by Ispe 1946964573 9781946964571

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ISBN 10: 1946964573 
ISBN 13: 9781946964571
Author: ISPE

GAMP aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.

Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. It highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.

The ISPE GAMP Community of Practice (CoP) performs regular ongoing assessments and reviews of GAMP knowledge against current practices and regulatory and technology developments. ISPE GAMP 5 (Second Edition) therefore embraces and reflects:

• Increased importance of service providers, which includes encouraging regulated companies to maximize supplier involvement to leverage knowledge, experience, and documentation where possible
• Evolving approaches to software development, emphasizing that the GAMP specification and verification approach is not inherently linear but also fully supports iterative and incremental methods
• Increased use of software tools and automation to achieve greater control, higher quality, and lower risks throughout the life cycle

Furthermore, this Guide highlights the importance of applying “critical thinking” by knowledgeable and experienced SMEs when defining the appropriate approach for specific circumstances.

GAMP 5 Guide A Risk Based Approach to Compliant GxP Computerized Systems 2nd Table of contents:

1 Introduction

1.1 Rationale for GAMP 5 Second Edition

1.2 New and Revised Material

1.3 Purpose

1.4 Scope

1.4.1 Supplier Aspects

1.5 Business Benefits

1.6 Structure

1.6.1 Overview of GAMP Documentation Structure

1.6.2 GAMP 5 Main Body Structure

2 Key Concepts

2.1 Overview

2.1.1 Product and Process Understanding

2.1.2 Life Cycle Approach within a QMS

2.1.3 Scalable Life Cycle Activities

2.1.4 Science-Based Quality Risk Management

2.1.5 Leveraging Supplier Involvement

2.2 Key Terms

3 Life Cycle Approach

3.1 Computerized System Life Cycle

3.2 Specification and Verification

3.3 Computerized System Validation Framework

3.4 Critical Thinking Through the Life Cycle

4 Life Cycle Phases

4.1 Concept

4.2 Project

4.2.1 Planning

4.2.2 Specification, Configuration, and Coding

4.2.3 Verification

4.2.4 Reporting and Release

4.2.5 Supporting Processes

4.2.6 Practical Examples

4.3 Operation

4.3.1 Handover

4.3.2 Service Management and Performance Monitoring

4.3.3 Incident and Problem Management and CAPA

4.3.4 Change Management

4.3.5 Periodic Review

4.3.6 Continuity Management

4.3.7 Security and System Administration

4.3.8 Record Management

4.4 Retirement

4.4.1 Withdrawal

4.4.2 Decommissioning

4.4.3 Disposal

4.4.4 Data Migration

5 Quality Risk Management

5.1 Overview

5.2 Science-Based Quality Risk Management

5.3 Quality Risk Management Process

6 Regulated Company Activities

6.1 Governance for Achieving Compliance

6.1.1 Computerized Systems Policies and Procedures

6.1.2 Identifying Clear Roles and Responsibilities

6.1.3 Training6.1.4 Managing Supplier Relationships

6.1.5 Maintaining the System Inventory

6.1.6 Planning for Validation

6.1.7 Continual Improvement Activities

6.1.8 Data Governance

6.2 System-Specific Activities

6.2.1 Identify Compliance Standards

6.2.2 Identify System

6.2.3 Identify Key Individuals

6.2.4 Requirements Specification

6.2.5 Determine Strategy for Achieving Compliance and Fitness for Intended Use

6.2.6 Planning

6.2.7 System Specifications

6.2.8 Development and Review of Software for Custom Applications

6.2.9 Test Strategy and Testing

6.2.10 Reporting and Release

6.2.11 Maintaining System Compliance During Operation

6.2.12 System Retirement

7 Supplier Activities

7.1 Supplier Products, Applications, and Services

7.1.1 Standard Product (GAMP Category 3)

7.1.2 Configured Product (GAMP Category 4)

7.1.3 Custom Application (GAMP Category 5)

7.1.4 Service Provision

7.2 Supplier Good Practices

7.3 Quality Management System

7.4 Requirements

7.5 Supplier Quality Planning

7.5.1 Prototyping

7.6 Sub-Supplier Assessments

7.7 Specifications

7.8 Design Reviews

7.9 Software Production/Configuration

7.10 Testing

7.11 Commercial Release

7.12 User Documentation and Training

7.13 System Support and Maintenance During Operation

7.14 System Replacement and Retirement

8 Efficiency Improvements

8.1 Establishing Verifiable and Objective User Requirements

8.2 Making Risk-Based Decisions

8.3 Leveraging Supplier Input

8.4 Leveraging Existing Information

8.5 Using Efficient Testing Practices

8.5.1 Reuse of Test Results

8.5.2 Extent of Required Testing

8.5.3 Secondary Test Evidence

8.5.4 Use of Test Witnesses

8.6 Employing a Well-Managed Handover Process

8.7 Managing Changes Efficiently

8.8 Anticipating Data Archiving and Migration Needs

8.8.1 Different Retention Periods

8.8.2 Data Formats

8.8.3 Static and Dynamic Data

8.8.4 Data Ownership

8.9 Using Tools and Automation

Management Appendices

9 Appendix M1 – Validation Planning

9.1 Introduction

9.1.1 Changes from GAMP 5 First Edition

9.2 Scope

9.3 Computerized System Validation Plans

9.3.1 General Guidelines

9.3.2 Roles and Responsibilities

9.3.3 Contents of the Plan

9.4 Validation Policies

9.5 Validation Master Plans

9.5.1 General Guidelines

9.5.2 Roles and Responsibilities

9.5.3 Contents of the VMP

10 Appendix M2 – Supplier Assessment

10.1 Introduction

10.1.1 Changes from GAMP 5 First Edition

10.2 Reasons for Supplier Assessment

10.3 Types of Assessment

10.4 Assessment Process

10.4.1 Need for Audit

10.4.2 Basic Assessment

10.4.3 Postal/Email Audits

10.4.4 On-Site/Virtual Online Audit – Preparation and Organization

10.4.5 On-Site/Virtual Online Audit – Performing the Audit

10.4.6 Audit Report for Postal/Email and On-Site/Virtual Online Audits

10.4.7 Supplier Acceptance and Rejection

10.4.8 Corrective Actions and Follow-up Audits

10.4.9 Re-Evaluation

10.5 Joint Audits

10.6 Shared Audit Reports

10.7 Corporate Audits

10.8 Supplier Preparation for an Audit

10.9 Supplier Certification

10.10 International Standards and Certification

11 Appendix M3 – Science-Based Quality Risk Management

11.1 Introduction

11.1.1 Changes from GAMP 5 First Edition

11.2 Scope

11.3 Benefits

11.4 Roles and Responsibilities

11.5 Guidance

11.5.1 Scalability of the Process

11.5.2 Applying Risk Management Based on the Business Process

11.5.3 Risk Management Throughout the System Life Cycle

11.5.4 Risk Assessment Method

11.5.5 The Selection and Use of Controls

11.5.6 Residual Risk

11.5.7 Scaling Life Cycle Activities

11.5.8 Risk Communication and Documentation

11.5.9 Risk Management for Outsourced Activities

11.6 Other Risk Assessment Methods and Tools

11.7 Examples

11.7.1 Example 1 – Approaches for Different Categories of Systems

11.7.2 Example 2 – Determining System and Functional Impact

11.7.3 Example 3 – Functional Risk Assessment Based on Impact

11.7.4 Example 4 – Example of Medium and High-Impact Functions

12 Appendix M4 – Categories of Software and Hardware

12.1 Introduction

12.1.1 Changes from GAMP 5 First Edition

12.2 Using the GAMP Categories

12.3 Categories of Software

12.3.1 Category 1 – Infrastructure Software, Tools, and IT Services

12.3.2 Category 2 – Not Used

12.3.3 Category 3 – Standard System Components

12.3.4 Category 4 – Configured Components

12.3.5 Category 5 – Custom Applications and Components

12.3.6 Typical Examples and Approaches

12.4 Categories of Hardware

12.4.1 Hardware Category 1 – Standard Hardware Components

12.4.2 Hardware Category 2 – Custom Built Hardware Components

13 Appendix M5 – Design Review and Traceability

13.1 Introduction

13.1.1 Changes from GAMP 5 First Edition

13.2 Scope

13.3 Design Review

13.4 Traceability

13.4.1 Introduction

13.4.2 Principles

13.4.3 Methods of Achieving Traceability

13.4.4 Additional Requirements Traceability Considerations

13.4.5 Practical Issues to Consider

14 Appendix M6 – Supplier Quality Planning

14.1 Introduction

14.1.1 Changes from GAMP 5 First Edition

14.2 Scope

14.3 Considerations of Quality Planning

14.3.1 Quality Agreements

14.3.2 Quality Planning Considerations

14.4 Projects Involving Multiple Organizations

15 Appendix M7 – Validation Reporting

15.1 Introduction

15.1.1 Changes from GAMP 5 First Edition

15.2 Scope

15.3 Roles and Responsibilities

15.4 Reporting Process

15.4.1 Contents of the Computerized System Validation Report

16 Appendix M8 – Project Change and Configuration Management

16.1 Introduction

16.1.1 Changes from GAMP 5 First Edition

16.2 Scope

16.3 Guidelines

16.3.1 Configuration Management

16.3.2 Change Management

17 Appendix M9 – Documentation and Information Management

17.1 Introduction

17.1.1 Changes from GAMP 5 First Edition

17.2 Scope

17.3 Guidelines

17.3.1 Documentation Production

17.3.2 Documentation Review

17.3.3 Documentation Approval

17.3.4 Documentation Issue

17.3.5 Documentation Changes

17.3.6 Documentation Withdrawal

17.3.7 Documentation Records and Storage

18 Appendix M10 – System Retirement

18.1 Introduction

18.1.1 Changes from GAMP 5 First Edition

18.2 Scope

18.3 System Retirement Planning

18.3.1 General Guidelines

18.3.2 Contents of the System Retirement Plan

18.4 System Retirement Reporting

19 Appendix M11 – IT Infrastructure

19.1 Introduction

19.1.1 Changes from GAMP 5 First Edition

19.1.2 Further Reading

19.2 Principles and Assumptions

19.2.1 Scope of Infrastructure Qualification

19.2.2 Infrastructure Qualification versus Application Validation

19.2.3 Component-Based Nature of Infrastructure

19.2.4 Infrastructure Automation

19.2.5 Tools

19.3 Risk Management and Infrastructure

19.4 The Role of Quality

19.5 IT Processes in Scope for Infrastructure Qualification

19.5.1 Security Management

19.5.2 Backup and Recovery

19.5.3 Archive and Restore

19.5.4 Change Management

19.5.5 Configuration Management

19.5.6 Disaster Recovery and Business Continuity Planning

19.5.7 Other IT Processes

19.6 Cloud Infrastructure

19.7 Continual Improvement

20 Appendix M12 – Critical Thinking

20.1 Introduction

20.1.1 Changes from GAMP 5 First Edition

20.2 Scope

20.3 Guidance

20.3.1 Facilitating Critical Thinking

20.3.2 Planning

20.3.3 Quality Risk Management

20.3.4 Requirements

20.3.5 Supplier Assessment and Selection

20.3.6 Testing

20.3.7 Managing Build and Configuration

20.3.8 Operation and Maintenance

20.3.9 Periodic Review

20.3.10 Retirement

20.3.11 Inspection Readiness

20.3.12 Organizational Capability

Development Appendices

21 Appendix D1 – Specifying Requirements

21.1 Introduction

21.1.1 Changes from GAMP 5 First Edition

21.2 Scope

21.3 Guidance

21.3.1 General Guidelines

21.3.2 Ownership

21.3.3 Contents of the Requirement Specification

21.3.4 Out of Scope Topics

21.4 Requirements Capture

21.4.1 Requirements-Capture Process

21.4.2 Requirements Planning Pitfalls

22 Appendix D2 (Retired)

23 Appendix D3 – Configuration and Design

23.1 Introduction

23.1.1 Changes from GAMP 5 First Edition

23.2 Scope

23.3 Guidance

23.3.1 Overview of Configuration and Design

23.3.2 General Guidelines

23.3.3 Information Required

23.3.4 Glossary

24 Appendix D4 – Management, Development, and Review of Software

24.1 Introduction

24.1.1 Changes from GAMP 5 First Edition

24.2 Scope

24.3 Guidance

24.3.1 Software Development

24.3.2 Source Code Review

24.3.3 Third-Party Software

25 Appendix D5 – Testing of Computerized Systems

25.1 Introduction

25.1.1 Changes from GAMP 5 First Edition

25.2 Scope

25.3 Roles and Responsibilities

25.4 Influences on Test Activities

25.5 Test Planning/Coverage

25.5.1 Test Management Processes

25.5.2 Test Cases

25.5.3 Executing Tests

25.5.4 Reviewing and Reporting Completed Tests

25.6 Types of Testing

25.6.1 Test Types Unique to Unscripted Testing

25.6.2 Other Test Types

25.6.3 Contractual or Acceptance Testing

25.7 Test Environments

25.8 Leveraging Previous Testing Including Supplier Testing

25.8.1 Supplier Testing

25.8.2 Ongoing Life Cycle Maintenance

25.8.3 Testing in Multiple Environments

25.9 Testing Applied to Different Software Categories

25.9.1 Aspects that Apply to all Systems

25.9.2 Typical Testing Activities for a Standard Product

25.9.3 Typical Testing Activities for Configured Functionality

25.9.4 Typical Testing Activities for a Custom Application

26 Appendix D6 – System Descriptions

26.1 Introduction

26.1.1 Changes from GAMP 5 First Edition

26.2 Scope

26.3 Guidance

26.3.1 General Guidelines

26.3.2 Contents of the Document

27 Appendix D7 – Data Migration

27.1 Introduction

27.1.1 Changes from GAMP 5 First Edition

27.2 Scope

27.3 Guidance

27.3.1 General Guidelines

27.3.2 Quality Management

27.3.3 Areas of Concern

27.3.4 Data Migration Plan

27.3.5 Data Migration Report

28 Appendix D8 – Agile Software Development

28.1 Introduction

28.1.1 Changes from GAMP 5 First Edition

28.2 Scope

28.3 Guidance

28.3.1 Agile Basics

28.3.2 User Requirements

28.3.3 Mindset and Culture

28.3.4 Tools Instead of Documents

28.3.5 Approvals and Acceptance

28.3.6 Software Development and IT Operations (DevOps)

28.4 Agile Approach to Quality

29 Appendix D9 – Software Tools

29.1 Introduction

29.1.1 Changes from GAMP 5 First Edition

29.2 Scope

29.3 Guidance

29.3.1 Selection of Tools

29.3.2 Risk Assessment

29.3.3 Inventory/Deployment

29.3.4 Installation and Configuration

29.3.5 Life Cycle Management

29.3.6 Security Considerations

29.3.7 Data and Records

29.3.8 Approvals

29.3.9 Tools over Documentation

30 Appendix D10 – Distributed Ledger Systems (Blockchain)

30.1 Introduction

30.1.1 GAMP 5 Context and Application

30.1.2 Changes from GAMP 5 First Edition

30.2 Scope

30.2.1 Objectives

30.2.2 Governance of Large-Scale Decentralized Networks

30.3 Guidance

30.3.1 Concept Phase

30.3.2 Project Phase

30.3.3 Retirement or Migration

30.4 Other Considerations

30.4.1 Use of Emerging Technologies

30.4.2 Reliance on Cryptography and Proofs in Place of Trusted Systems

30.4.3 Role of Cryptocurrencies and Incentives on Public Networks as They Relate to GxP Applications

30.4.4 Achieving Privacy and Confidentiality on Public Networks

31 Appendix D11 – Artificial Intelligence and Machine Learning (AI/ML)

31.1 Introduction

31.1.1 Changes from GAMP 5 First Edition

31.2 Scope

31.3 Guidance

31.3.1 Life Cycle Approach

31.3.2 Concept Phase

31.3.3 Project Phase

31.3.4 Operation Phase

31.3.5 Supporting Processes

Operation Appendices

32 Appendix O – Introduction to Operation Appendices

33 Appendix O1 – Handover

33.1 Introduction

33.1.1 Changes from GAMP 5 First Edition

33.2 Key Requirements

33.3 Process

33.4 Guidance

33.4.1 General Approach

33.4.2 Responsibilities

34 Appendix O2 – Establishing and Managing Support Services

34.1 Introduction

34.1.1 Changes from GAMP 5 First Edition

34.2 Key Requirements

34.3 Process

34.4 Guidance

34.4.1 General Approach

34.4.2 Responsibilities

34.4.3 General Guidelines

34.4.4 Service Level Agreements

34.4.5 Measurement, Reporting, and Review

34.4.6 Managing Contract Exit

35 Appendix O3 – System Monitoring

35.1 Introduction

35.1.1 Changes from GAMP 5 First Edition

35.2 Key Requirements

35.3 Process

35.4 Guidance

35.4.1 General Approach

35.4.2 Responsibilities

35.4.3 System Monitoring Considerations

35.4.4 System Monitoring Tools

35.4.5 Manual Monitoring

36 Appendix O4 – Incident Management and Problem Management

36.1 Introduction

36.1.1 Changes from GAMP 5 First Edition

36.2 Key Requirements

36.3 Process

36.4 Guidance

36.4.1 Incident Management

36.4.2 Problem Management

36.4.3 Determining GxP Impact

36.4.4 Incident and Problem Records

37 Appendix O5 – Corrective and Preventive Action

37.1 Introduction

37.1.1 Changes from GAMP 5 First Edition

37.2 Key Requirements

37.3 Process

37.4 Guidance

37.4.1 General Approach

37.4.2 Responsibilities

37.4.3 CAPA Process

38 Appendix O6 – Operational Change and Configuration Management

38.1 Introduction

38.1.1 Changes from GAMP 5 First Edition

38.2 Key Requirements

38.3 Process

38.4 Guidance

38.4.1 Responsibilities

38.4.2 General Approach

38.4.3 Types of Change

38.4.4 Business, IT, Engineering, and Service Provider Change Processes

38.4.5 Configuration Management

38.4.6 Cloud Service Provider Changes

38.4.7 Software Development Change Management

39 Appendix O7 (Retired)

40 Appendix O8 – Periodic Review

40.1 Introduction

40.1.1 Changes from GAMP 5 First Edition

40.2 Key Requirements

40.3 Process

40.4 Guidance

40.4.1 General Approach

40.4.2 Responsibilities

40.4.3 Timing and Scheduling

40.4.4 Review of a System

41 Appendix O9 – Backup and Restore

41.1 Introduction

41.1.1 Changes from GAMP 5 First Edition

41.2 Key Requirements

41.3 Process

41.4 Guidance

41.4.1 Responsibilities

41.4.2 Risk Assessment

41.4.3 Backup Strategy

41.4.4 Backup and Restore Procedures

41.4.5 Implementation of Backup Technologies and Services

41.4.6 Verification and Monitoring

41.4.7 Specific Considerations

42 Appendix O10 – Business Continuity Management

42.1 Introduction

42.1.1 Changes from GAMP 5 First Edition

42.2 Key Requirements

42.3 Process

42.4 Guidance

42.4.1 Business Continuity Planning

42.4.2 Disaster Recovery Planning

42.4.3 Responsibilities

43 Appendix O11 – Security Management

43.1 Introduction

43.1.1 Changes from GAMP 5 First Edition

43.2 Key Requirements

43.3 Process

43.4 Guidance

43.4.1 Organizational Controls

43.4.2 Information Security Management System (ISMS)

43.4.3 Physical and Technical Controls

43.4.4 Monitoring and Incident Management

43.4.5 Cloud Environments

43.4.6 Auditing

43.4.7 Management Review

43.4.8 Security Patching and GxP Compliance

43.4.9 Security Certification Programs

44 Appendix O12 – System Administration

44.1 Introduction

44.1.1 Changes from GAMP 5 First Edition

44.2 Key Requirements

44.3 Process

44.4 Guidance

44.4.1 General Approach

44.4.2 Responsibilities

45 Appendix O13 – Archiving and Retrieval

45.1 Introduction

45.1.1 Changes from GAMP 5 First Edition

45.2 Key Requirements

45.3 Process

45.4 Guidance

45.4.1 General Approach

45.4.2 Responsibilities

45.4.3 Policies and Strategy

45.4.4 Archival and Retention

45.4.5 Retrieval

45.4.6 Copying/Migrating Records to an Alternative Format

45.4.7 Retaining Existing Systems

45.4.8 Return of Archived Records

Special Interest Topics Appendices

46 Appendix S1 – Alignment with ASTM E2500

46.1 Introduction

46.2 Focusing on Patient Risk

46.3 Different Types of Computerized Systems

46.4 Terminology

47 Appendix S2 – Electronic Production Records

47.1 Introduction

47.1.1 Changes from GAMP 5 First Edition

47.2 Considerations for Electronic Production Records

47.2.1 GxP-Relevant Data

47.2.2 Audit Trail Terminology

47.2.3 Data Audit Trail Review

47.2.4 EPR Data Types

47.2.5 Data Capturing/Data Input

47.2.6 Data Processing

47.2.7 Data Output

47.3 Understanding Manufacturing, Production Processes, and Data Flow

47.4 Completion of Production Activities

47.4.1 Review by Exception

47.4.2 Implementation of RBE

47.5 Migration to Real-Time Disposition

47.6 Technology and Architecture Considerations

47.6.1 Cloud Computing

47.6.2 Blockchain

48 Appendix S3 – End User Applications Including Spreadsheets

48.1 Introduction

48.1.1 Changes from GAMP 5 First Edition

48.2 Application Types

48.2.1 Disposable Spreadsheets

48.2.2 Spreadsheets Retained as Documents

48.2.3 Spreadsheets as Databases

48.2.4 Template Applications

48.2.5 True Desktop Databases

48.2.6 Other End User Applications

48.3 Risk-Based Approach

48.3.1 Use of GAMP Categories

48.4 Risk-Based Controls

48.4.1 Degree of Verification

48.4.2 Security Control

48.4.3 Change Control

48.4.4 Control of the Infrastructure

48.5 Examples of Typical Approaches

49 Appendix S4 – Patch and Update Management

49.1 Introduction

49.1.1 Changes from GAMP 5 First Edition

49.2 Approach to Patch and Update Management

49.2.1 Configuration Management

50 Appendix S5 (Retired)

51 Appendix S6 – Organizational Change

51.1 Introduction

51.1.1 Changes from GAMP 5 First Edition

51.2 Initiators for Change

51.3 Scope and Impact of Change

51.4 Organizational Factors

51.5 Outsourcing

51.6 Loss of a Supplier

51.7 Risk Assessment of Organizational Change

51.8 Affected Stakeholders

General Appendices

52 Appendix G1 – References

53 Appendix G2 – Glossary

53.1 Acronyms and Abbreviations

53.2 Definitions

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