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GAMP 5 - Good Automated Manufacturing Practice

Self-Assess
International
v2nd Edition (2022)
7 domains
11 controls

GAMP 5 (Good Automated Manufacturing Practice 5) is the INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING (ISPE) flagship guide for Computerised Systems Validation in GxP-regulated environments (pharmaceutical + medical device + biotech + healthcare manufacturing + laboratories). Current edition GAMP 5 SECOND EDITION published July 2022 + supersedes the 2008 First Edition. KEY CONCEPTS: (a) RISK-BASED APPROACH - effort proportional to risk + complexity + regulatory impact; (b) LIFE CYCLE APPROACH - V-Model lifecycle with Specification + Verification phases mirrored; (c) CRITICAL THINKING - applying judgment over checkbox compliance; (d) LEVERAGE SUPPLIER INVOLVEMENT - reduce duplication via supplier qualification + documentation reuse + audit; (e) SCALABILITY - approach scales from small bench instruments to enterprise ERP/MES; (f) GxP regulatory alignment - 21 CFR Part 11 (FDA Electronic Records + Electronic Signatures) + EU Annex 11 (Computerised Systems) + ICH Q9 Quality Risk Management + ICH Q10 Pharmaceutical Quality System + FDA Computer Software Assurance (CSA) 2023 Draft Guidance. 5 SOFTWARE CATEGORIES (Appendix M4): Category 1 INFRASTRUCTURE (operating systems + databases + network); Category 2 was deprecated in 1st Edition; Category 3 NON-CONFIGURED PRODUCTS (commercial off-the-shelf); Category 4 CONFIGURED PRODUCTS (commercial with configuration); Category 5 CUSTOM APPLICATIONS (in-house developed). 2ND EDITION (2022) UPDATES: AI + machine learning systems; cloud + SaaS; agile + iterative development; DevOps; data integrity by design; explicit critical thinking emphasis; data integrity ALCOA+ deepening; computer software assurance (FDA CSA Draft Guidance 2022) alignment + replacing some traditional CSV. APPLICATION: typical implementation includes URS (User Requirements Specification) + FS (Functional Specification) + DS (Design Specification) + IQ (Installation Qualification) + OQ (Operational Qualification) + PQ (Performance Qualification) + Traceability Matrix + Risk Assessment + Change Control + Periodic Review + Data Integrity Controls + Decommissioning. AUDITORS: FDA + EMA + MHRA + PMDA + Health Canada + Brazilian ANVISA + China NMPA + other regulators inspect against GAMP 5 + Part 11 + Annex 11 + national regulations.

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Framework Domains (7)

GAMP 5: 2nd Edition (2022) - AI/ML + Cloud + Agile + DevOps + Computer Software Assurance (CSA)

1 controls
Controls in the GAMP 5: 2nd Edition (2022) - AI/ML + Cloud + Agile + DevOps + Computer Software Assurance (CSA) domain of GAMP 5 - Good Automated Manufacturing Practice — 1 controls
CodeTitle
GAMP5-2nd-Edition-AI-Cloud-Agile-CSA2nd Edition (2022) - AI/ML, Cloud, Agile, DevOps and Computer Software Assurance (CSA)

GAMP 5: 5 Software Categories (Cat 1 Infrastructure, Cat 3 Non-Configured, Cat 4 Configured, Cat 5 Custom)

1 controls
Controls in the GAMP 5: 5 Software Categories (Cat 1 Infrastructure, Cat 3 Non-Configured, Cat 4 Configured, Cat 5 Custom) domain of GAMP 5 - Good Automated Manufacturing Practice — 1 controls
CodeTitle
GAMP5-Software-Categories5 Software Categories (Appendix M4) - Infrastructure, Non-Configured, Configured, Custom

GAMP 5: Data Integrity (ALCOA+), Electronic Records and 21 CFR Part 11 / EU Annex 11

1 controls
Controls in the GAMP 5: Data Integrity (ALCOA+), Electronic Records and 21 CFR Part 11 / EU Annex 11 domain of GAMP 5 - Good Automated Manufacturing Practice — 1 controls
CodeTitle
GAMP5-DataIntegrity-Part11-Annex11Data Integrity (ALCOA+), 21 CFR Part 11 + EU Annex 11 + Electronic Records

GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates

5 controls
Controls in the GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates domain of GAMP 5 - Good Automated Manufacturing Practice — 5 controls
CodeTitle
GAMP5-CrossMapping-NIST-ISOCrosswalk to NIST CSF, ISO 27001/27017, ISO 13485 (Medical Devices) and ITIL
GAMP5-Crosswalk-ICH-FDA-EMA-MHRACrosswalk to ICH Q9/Q10, FDA Part 11, EU Annex 11, MHRA Data Integrity and Sectoral Standards
GAMP5-ISPE-Status-Copyright-CoordinationISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates
GAMP5-Implementation-RoadmapGAMP 5 Implementation Roadmap - Organizational Roles, Training and Tooling
GAMP5-Status-2024-2025-CSA-AIGAMP 5 Status, FDA CSA Final Guidance and AI/ML in Pharma 2024-2025

GAMP 5: Risk-Based Approach, Critical Thinking and 5 Key Concepts

1 controls
Controls in the GAMP 5: Risk-Based Approach, Critical Thinking and 5 Key Concepts domain of GAMP 5 - Good Automated Manufacturing Practice — 1 controls
CodeTitle
GAMP5-Risk-CriticalThinkingRisk-Based Approach, Critical Thinking and 5 Key Concepts

GAMP 5: Supplier Assessment, Operational Phase, Change Control and Periodic Review

1 controls
Controls in the GAMP 5: Supplier Assessment, Operational Phase, Change Control and Periodic Review domain of GAMP 5 - Good Automated Manufacturing Practice — 1 controls
CodeTitle
GAMP5-Supplier-Operations-Change-PeriodicSupplier Assessment, Operational Phase, Change Control and Periodic Review

GAMP 5: V-Model Lifecycle and Specification Documents (URS, FS, DS, IQ, OQ, PQ)

1 controls
Controls in the GAMP 5: V-Model Lifecycle and Specification Documents (URS, FS, DS, IQ, OQ, PQ) domain of GAMP 5 - Good Automated Manufacturing Practice — 1 controls
CodeTitle
GAMP5-Lifecycle-VModel-URS-FS-DS-IQOQPQV-Model Lifecycle - URS + FS + DS + IQ + OQ + PQ + Traceability

Your Compliance Coverage

If you comply with GAMP 5 - Good Automated Manufacturing Practice, you already cover:

Annex 11 to EU GMP - Computerised Systems

45%

5 controls mapped

Compare →

OWASP Top 10:2025

36%

4 controls mapped

Compare →

OWASP DevSecOps Maturity Model (DSOMM)

36%

4 controls mapped

Compare →

+ 88 more: Azure Security Benchmark (36%), AWS Well-Architected Security Pillar (36%)

See all 91 mapped frameworks ↓

Maps to 91 other frameworks

11 total controls
Annex 11 to EU GMP - Computerised Systems
5 source controls mapped|7 target controls covered
45%
OWASP Top 10:2025
4 source controls mapped|3 target controls covered
36%
OWASP DevSecOps Maturity Model (DSOMM)
4 source controls mapped|4 target controls covered
36%
Azure Security Benchmark
4 source controls mapped|8 target controls covered
36%
AWS Well-Architected Security Pillar
4 source controls mapped|8 target controls covered
36%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|3 target controls covered
36%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
4 source controls mapped|9 target controls covered
36%
ISO/IEC 27011:2024
4 source controls mapped|5 target controls covered
36%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|2 target controls covered
27%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|4 target controls covered
27%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|2 target controls covered
27%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
3 source controls mapped|3 target controls covered
27%
NIST AI Risk Management Framework (AI RMF 1.0)
3 source controls mapped|4 target controls covered
27%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|2 target controls covered
27%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|4 target controls covered
27%
21 CFR Part 211 - Current Good Manufacturing Practice
3 source controls mapped|2 target controls covered
27%
OWASP ASVS
3 source controls mapped|2 target controls covered
27%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
3 source controls mapped|3 target controls covered
27%
MITRE D3FEND
3 source controls mapped|2 target controls covered
27%
HKMA Cyber Resilience Assessment Framework (C-RAF)
3 source controls mapped|3 target controls covered
27%
APRA CPS 234
3 source controls mapped|3 target controls covered
27%
FTC GLBA Safeguards Rule (16 CFR Part 314)
3 source controls mapped|2 target controls covered
27%
ISO/IEC 27400:2022
3 source controls mapped|4 target controls covered
27%
ISO/IEC 27031:2011
3 source controls mapped|4 target controls covered
27%
FFIEC IT Examination Handbook
3 source controls mapped|3 target controls covered
27%
ASIS SPC.1-2009 - Organizational Resilience Standard
3 source controls mapped|2 target controls covered
27%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
3 source controls mapped|2 target controls covered
27%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
2 source controls mapped|4 target controls covered
18%
Canada ITSG-33 - IT Security Risk Management
2 source controls mapped|2 target controls covered
18%
APRA CPS 230 Operational Risk Management
2 source controls mapped|3 target controls covered
18%
API 1164
2 source controls mapped|7 target controls covered
18%
FBI CJIS Security Policy
2 source controls mapped|3 target controls covered
18%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
2 source controls mapped|2 target controls covered
18%
AS9100D - Aerospace Quality Management System
2 source controls mapped|2 target controls covered
18%
ISO/IEC 27003:2017
2 source controls mapped|2 target controls covered
18%
ISO 19011
2 source controls mapped|2 target controls covered
18%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|1 target controls covered
18%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|1 target controls covered
18%
TEFCA - Trusted Exchange Framework and Common Agreement
2 source controls mapped|2 target controls covered
18%
SWIFT CSCF
2 source controls mapped|1 target controls covered
18%
Regulation on the European Health Data Space (EHDS)
2 source controls mapped|3 target controls covered
18%
Protective Security Policy Framework (PSPF) Release 2024
2 source controls mapped|1 target controls covered
18%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|2 target controls covered
18%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
18%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
18%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
18%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
18%
ICH E6(R3) - Good Clinical Practice
2 source controls mapped|4 target controls covered
18%
ICAO Annex 17 - Aviation Security (AVSEC)
2 source controls mapped|1 target controls covered
18%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|3 target controls covered
18%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
2 source controls mapped|2 target controls covered
18%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|2 target controls covered
18%
ISO/IEC 38500:2024 - Governance of IT
2 source controls mapped|3 target controls covered
18%
IEC 60601-1 - Medical Electrical Equipment Safety
2 source controls mapped|3 target controls covered
18%
ISO/IEC 29100:2024
2 source controls mapped|3 target controls covered
18%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
18%
ISO 31000:2018
2 source controls mapped|1 target controls covered
18%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
18%
IEC 62351 - Power Systems Communication Security
2 source controls mapped|1 target controls covered
18%
COBIT 2019
2 source controls mapped|1 target controls covered
18%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
2 source controls mapped|4 target controls covered
18%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
2 source controls mapped|3 target controls covered
18%
ISO/IEC 29134:2023
2 source controls mapped|3 target controls covered
18%
ISO/IEC 27014:2020
2 source controls mapped|3 target controls covered
18%
ISO/IEC 30111:2019
2 source controls mapped|3 target controls covered
18%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|1 target controls covered
18%
ISO/IEC 29147:2018
2 source controls mapped|3 target controls covered
18%
21 CFR Part 58 - Good Laboratory Practice (GLP)
2 source controls mapped|2 target controls covered
18%
Barbados Data Protection Act 2019
2 source controls mapped|1 target controls covered
18%
FedRAMP High
2 source controls mapped|1 target controls covered
18%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|1 target controls covered
18%
FedRAMP Moderate
2 source controls mapped|1 target controls covered
18%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|1 target controls covered
18%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|1 target controls covered
18%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
18%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
18%
Florida Digital Bill of Rights (FDBR)
2 source controls mapped|1 target controls covered
18%
Authorised Economic Operator (AEO) Programmes - Global Standards
1 source controls mapped|2 target controls covered
9%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
9%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
1 source controls mapped|1 target controls covered
9%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
1 source controls mapped|1 target controls covered
9%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
1 source controls mapped|1 target controls covered
9%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
9%
ASD Strategies to Mitigate Cyber Security Incidents
1 source controls mapped|6 target controls covered
9%
OWASP API Security Top 10 - 2023
1 source controls mapped|1 target controls covered
9%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|2 target controls covered
9%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|1 target controls covered
9%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
1 source controls mapped|4 target controls covered
9%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
9%
Aged Care Quality Standards (Australia)
1 source controls mapped|3 target controls covered
9%
COSO Internal Control - Integrated Framework (2013)
1 source controls mapped|2 target controls covered
9%
Compare GAMP 5 - Good Automated Manufacturing Practice with Annex 11 to EU GMP - Computerised Systems

Frequently Asked Questions

What is GAMP 5 - Good Automated Manufacturing Practice?

GAMP 5 - Good Automated Manufacturing Practice is a compliance framework from International with 7 domains and 11 controls. GAMP 5 (Good Automated Manufacturing Practice 5) is the INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING (ISPE) flagship guide for Computerised Systems Validation in GxP-regulated environments (pharmaceutical + medical device + biotech + healthcare manufacturing + laboratories). Current edition GAMP 5 SECOND EDITION published July 2022 + supersedes the 2008 First Edition. KEY CONCEPTS: (a) RISK-BASED APPROACH - effort proportional to risk + complexity + regulatory impact; (b) LIFE CYCLE APPROACH - V-Model lifecycle with Specification + Verification phases mirrored; (c) CRITICAL THINKING - applying judgment over checkbox compliance; (d) LEVERAGE SUPPLIER INVOLVEMENT - reduce duplication via supplier qualification + documentation reuse + audit; (e) SCALABILITY - approach scales from small bench instruments to enterprise ERP/MES; (f) GxP regulatory alignment - 21 CFR Part 11 (FDA Electronic Records + Electronic Signatures) + EU Annex 11 (Computerised Systems) + ICH Q9 Quality Risk Management + ICH Q10 Pharmaceutical Quality System + FDA Computer Software Assurance (CSA) 2023 Draft Guidance. 5 SOFTWARE CATEGORIES (Appendix M4): Category 1 INFRASTRUCTURE (operating systems + databases + network); Category 2 was deprecated in 1st Edition; Category 3 NON-CONFIGURED PRODUCTS (commercial off-the-shelf); Category 4 CONFIGURED PRODUCTS (commercial with configuration); Category 5 CUSTOM APPLICATIONS (in-house developed). 2ND EDITION (2022) UPDATES: AI + machine learning systems; cloud + SaaS; agile + iterative development; DevOps; data integrity by design; explicit critical thinking emphasis; data integrity ALCOA+ deepening; computer software assurance (FDA CSA Draft Guidance 2022) alignment + replacing some traditional CSV. APPLICATION: typical implementation includes URS (User Requirements Specification) + FS (Functional Specification) + DS (Design Specification) + IQ (Installation Qualification) + OQ (Operational Qualification) + PQ (Performance Qualification) + Traceability Matrix + Risk Assessment + Change Control + Periodic Review + Data Integrity Controls + Decommissioning. AUDITORS: FDA + EMA + MHRA + PMDA + Health Canada + Brazilian ANVISA + China NMPA + other regulators inspect against GAMP 5 + Part 11 + Annex 11 + national regulations. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does GAMP 5 - Good Automated Manufacturing Practice have?

GAMP 5 - Good Automated Manufacturing Practice has 11 controls organised across 7 domains. The largest domains are GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates (5 controls), GAMP 5: 2nd Edition (2022) - AI/ML + Cloud + Agile + DevOps + Computer Software Assurance (CSA) (1 controls), GAMP 5: 5 Software Categories (Cat 1 Infrastructure, Cat 3 Non-Configured, Cat 4 Configured, Cat 5 Custom) (1 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does GAMP 5 - Good Automated Manufacturing Practice map to?

GAMP 5 - Good Automated Manufacturing Practice maps to 91 other compliance frameworks. The top mapping partners are Annex 11 to EU GMP - Computerised Systems (45% coverage), OWASP Top 10:2025 (36% coverage), OWASP DevSecOps Maturity Model (DSOMM) (36% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with GAMP 5 - Good Automated Manufacturing Practice compliance?

Start your GAMP 5 - Good Automated Manufacturing Practice compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about GAMP 5 - Good Automated Manufacturing Practice requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 11 controls and track your progress.

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