GAMP5-2nd-Edition-AI-Cloud-Agile-CSA | 2nd Edition (2022) - AI/ML, Cloud, Agile, DevOps and Computer Software Assurance (CSA) | 27 |
GAMP5-CrossMapping-NIST-ISO | Crosswalk to NIST CSF, ISO 27001/27017, ISO 13485 (Medical Devices) and ITIL | 0 |
GAMP5-Crosswalk-ICH-FDA-EMA-MHRA | Crosswalk to ICH Q9/Q10, FDA Part 11, EU Annex 11, MHRA Data Integrity and Sectoral Standards | 0 |
GAMP5-DataIntegrity-Part11-Annex11 | Data Integrity (ALCOA+), 21 CFR Part 11 + EU Annex 11 + Electronic Records | 0 |
GAMP5-ISPE-Status-Copyright-Coordination | ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates | 0 |
GAMP5-Implementation-Roadmap | GAMP 5 Implementation Roadmap - Organizational Roles, Training and Tooling | 0 |
GAMP5-Lifecycle-VModel-URS-FS-DS-IQOQPQ | V-Model Lifecycle - URS + FS + DS + IQ + OQ + PQ + Traceability | 68 |
GAMP5-Risk-CriticalThinking | Risk-Based Approach, Critical Thinking and 5 Key Concepts | 69 |
GAMP5-Software-Categories | 5 Software Categories (Appendix M4) - Infrastructure, Non-Configured, Configured, Custom | 1 |
GAMP5-Status-2024-2025-CSA-AI | GAMP 5 Status, FDA CSA Final Guidance and AI/ML in Pharma 2024-2025 | 0 |
GAMP5-Supplier-Operations-Change-Periodic | Supplier Assessment, Operational Phase, Change Control and Periodic Review | 28 |
1 | Chapter 1 Introduction: rationale, new material, purpose, scope, benefits and structure | 0 |
2 | Chapter 2 Key Concepts | 0 |
2.1.1 | 2.1.1 Product and Process Understanding | 0 |
2.1.2 | 2.1.2 Life Cycle Approach within a Quality Management System | 0 |
2.1.3 | 2.1.3 Scalable Life Cycle Activities | 0 |
2.1.4 | 2.1.4 Science-Based Quality Risk Management | 0 |
2.1.5 | 2.1.5 Leveraging Supplier Involvement | 0 |
2.2 | 2.2 Key Terms | 0 |
3 | Chapter 3 Life Cycle Approach | 0 |
3.1 | 3.1 Computerized System Life Cycle | 0 |
3.2 | 3.2 Specification and Verification | 0 |
3.3 | 3.3 Computerized System Validation Framework | 0 |
3.4 | 3.4 Critical Thinking Through the Life Cycle | 0 |
4 | Chapter 4 Life Cycle Phases | 0 |
4.1 | 4.1 Concept Phase | 0 |
4.2 | 4.2 Project Phase | 0 |
4.2.1 | 4.2.1 Project Planning | 0 |
4.2.2 | 4.2.2 Specification, Configuration and Coding | 0 |
4.2.3 | 4.2.3 Verification | 0 |
4.2.4 | 4.2.4 Reporting and Release | 0 |
4.2.5 | 4.2.5 Supporting Processes | 0 |
4.2.5.1 | 4.2.5.1 Risk Management as a Supporting Process | 0 |
4.2.5.2 | 4.2.5.2 Project Change and Configuration Management | 0 |
4.2.5.3 | 4.2.5.3 Design Review | 0 |
4.2.5.4 | 4.2.5.4 Traceability | 0 |
4.2.5.5 | 4.2.5.5 Documentation Management and Knowledge Management | 0 |
4.2.6 | 4.2.6 Specification and Verification by Software Category | 0 |
4.3 | 4.3 Operation Phase | 0 |
4.3.1 | 4.3.1 Operation: Handover | 0 |
4.3.2 | 4.3.2 Operation: Service Management and Performance Monitoring | 0 |
4.3.3 | 4.3.3 Operation: Incident and Problem Management and CAPA | 0 |
4.3.4 | 4.3.4 Operation: Change and Configuration Management | 0 |
4.3.5 | 4.3.5 Operation: Periodic Review | 0 |
4.3.6 | 4.3.6 Operation: Continuity Management | 0 |
4.3.7 | 4.3.7 Operation: Security and System Administration | 0 |
4.3.8 | 4.3.8 Operation: Record Management | 0 |
4.4 | 4.4 Retirement Phase: Withdrawal, Decommissioning and Disposal | 0 |
5 | Chapter 5 Quality Risk Management | 0 |
5.1 | 5.1 Overview of Quality Risk Management | 0 |
5.2 | 5.2 Science-Based Quality Risk Management | 0 |
5.3 | 5.3 Quality Risk Management Process | 0 |
6 | Chapter 6 Regulated Company Activities | 0 |
6.1 | 6.1 Governance for Achieving Compliance | 0 |
6.1.1 | 6.1.1 Computerized Systems Policies and Procedures | 0 |
6.1.2 | 6.1.2 Identifying Clear Roles and Responsibilities | 0 |
6.1.3 | 6.1.3 Training | 0 |
6.1.4 | 6.1.4 Managing Supplier Relationships | 0 |
6.1.5 | 6.1.5 Maintaining the System Inventory | 0 |
6.1.6 | 6.1.6 Planning for Validation | 0 |
6.1.7 | 6.1.7 Continual Improvement Activities | 0 |
6.1.8 | 6.1.8 Data Governance | 0 |
6.2 | 6.2 System-Specific Activities | 0 |
6.2.1 | 6.2.1 Identify Compliance Standards | 0 |
6.2.10 | 6.2.10 Reporting and Release | 0 |
6.2.11 | 6.2.11 Maintaining System Compliance During Operation | 0 |
6.2.12 | 6.2.12 System Retirement | 0 |
6.2.2 | 6.2.2 Identify System | 0 |
6.2.3 | 6.2.3 Identify Key Individuals | 0 |
6.2.4 | 6.2.4 Requirements Specification | 0 |
6.2.5 | 6.2.5 Determine Strategy for Achieving Compliance and Fitness for Intended Use | 0 |
6.2.6 | 6.2.6 Planning | 0 |
6.2.7 | 6.2.7 System Specifications and Design Reviews | 0 |
6.2.8 | 6.2.8 Development and Review of Software for Custom Applications | 0 |
6.2.9 | 6.2.9 Test Strategy and Testing | 0 |
7 | Chapter 7 Supplier Activities | 0 |
7.1 | 7.1 Supplier Products, Applications and Services | 0 |
7.10 | 7.10 Supplier Testing | 0 |
7.11 | 7.11 Commercial Release | 0 |
7.12 | 7.12 User Documentation and Training | 0 |
7.13 | 7.13 System Support and Maintenance During Operation | 0 |
7.14 | 7.14 System Replacement and Retirement | 0 |
7.2 | 7.2 Supplier Good Practices | 0 |
7.3 | 7.3 Supplier Quality Management System | 0 |
7.4 | 7.4 Supplier Requirements | 0 |
7.5 | 7.5 Supplier Quality Planning and Prototyping | 0 |
7.6 | 7.6 Sub-Supplier Assessments | 0 |
7.7 | 7.7 Supplier Specifications | 0 |
7.8 | 7.8 Supplier Design Reviews | 0 |
7.9 | 7.9 Software Production and Configuration | 0 |
8 | Chapter 8 Efficiency Improvements | 0 |
8.1 | 8.1 Establishing Verifiable and Objective User Requirements | 0 |
8.2 | 8.2 Making Risk-Based Decisions | 0 |
8.3 | 8.3 Leveraging Supplier Input | 0 |
8.4 | 8.4 Leveraging Existing Information | 0 |
8.5 | 8.5 Using Efficient Testing Practices | 0 |
8.6 | 8.6 Employing a Well-Managed Handover Process | 0 |
8.7 | 8.7 Managing Changes Efficiently | 0 |
8.8 | 8.8 Anticipating Data Archiving and Migration Needs | 0 |
8.9 | 8.9 Using Tools and Automation | 0 |
D | Development Appendices (D1 to D11) | 0 |
D1 | Appendix D1 Specifying Requirements | 0 |
D10 | Appendix D10 Distributed Ledger Systems | 0 |
D11 | Appendix D11 Artificial Intelligence and Machine Learning | 0 |
D2 | Appendix D2 (Retired) Functional Specifications | 0 |
D3 | Appendix D3 Configuration and Design | 0 |
D4 | Appendix D4 Management, Development and Review of Software | 0 |
D5 | Appendix D5 Testing of Computerized Systems | 0 |
D6 | Appendix D6 System Descriptions | 0 |
D7 | Appendix D7 Data Migration | 0 |
D8 | Appendix D8 Agile Software Development | 0 |
D9 | Appendix D9 Software Tools | 0 |
G | Appendices G1 References and G2 Glossary | 0 |
M | Management Appendices (M1 to M12) | 0 |
M1 | Appendix M1 Validation Planning | 0 |
M10 | Appendix M10 System Retirement | 0 |
M11 | Appendix M11 IT Infrastructure | 0 |
M12 | Appendix M12 Critical Thinking | 0 |
M2 | Appendix M2 Supplier Assessment | 0 |
M3 | Appendix M3 Science-Based Quality Risk Management | 0 |
M4 | Appendix M4 Categories of Software and Hardware | 0 |
M5 | Appendix M5 Design Review and Traceability | 0 |
M6 | Appendix M6 Supplier Quality Planning | 0 |
M7 | Appendix M7 Validation Reporting | 0 |
M8 | Appendix M8 Project Change and Configuration Management | 0 |
M9 | Appendix M9 Documentation and Information Management | 0 |
O | Operation Appendices (O1 to O13) | 0 |
O1 | Appendix O1 Handover | 0 |
O10 | Appendix O10 Business Continuity Management | 0 |
O11 | Appendix O11 Security Management | 0 |
O12 | Appendix O12 System Administration | 0 |
O13 | Appendix O13 Archiving and Retrieval | 0 |
O2 | Appendix O2 Establishing and Managing Support Services | 0 |
O3 | Appendix O3 System Monitoring | 0 |
O4 | Appendix O4 Incident Management and Problem Management | 0 |
O5 | Appendix O5 Corrective and Preventive Action | 0 |
O6 | Appendix O6 Operational Change and Configuration Management | 0 |
O7 | Appendix O7 (Retired) Repair Activity | 0 |
O8 | Appendix O8 Periodic Review | 0 |
O9 | Appendix O9 Backup and Restore | 0 |
S | Special Interest Appendices (S1 to S6) | 0 |
S1 | Appendix S1 Alignment with ASTM E2500 | 0 |
S2 | Appendix S2 Electronic Production Records | 0 |
S3 | Appendix S3 End User Applications Including Spreadsheets | 0 |
S4 | Appendix S4 Patch and Update Management | 0 |
S5 | Appendix S5 (Retired) Managing Quality within an Outsourced IS/IT Environment | 0 |
S6 | Appendix S6 Organizational Change | 0 |