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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by design; explicit critical thinking emphasis; data integrity ALCOA+ deepening; computer software assurance (FDA CSA Draft Guidance 2022) alignment + replacing some traditional CSV.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.

Unverified

Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

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 →

Azure Security Benchmark

36%

4 controls mapped

Compare →

+ 162 more: AWS Well-Architected Security Pillar (36%), DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition) (36%)

See all 165 mapped frameworks ↓

Maps to 165 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%
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%
OWASP DevSecOps Maturity Model (DSOMM)
4 source controls mapped|7 target controls covered
36%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
4 source controls mapped|3 target controls covered
36%
ISO/IEC 27011:2024
4 source controls mapped|5 target controls covered
36%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|4 target controls covered
27%
Regulation (EU) 2019/1239 on the Maritime Single Window (MSW)
3 source controls mapped|2 target controls covered
27%
French Sapin II Law (Law No. 2016-1691)
3 source controls mapped|2 target controls covered
27%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|2 target controls covered
27%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
3 source controls mapped|4 target controls covered
27%
MiFID II / MiFIR
3 source controls mapped|2 target controls covered
27%
Law No. 09-08 on the Protection of Individuals with Regard to the Processing of Personal Data
3 source controls mapped|2 target controls covered
27%
Law No. 2013-450 of 19 June 2013 on the Protection of Personal Data
3 source controls mapped|2 target controls covered
27%
Pakistan Personal Data Protection Bill 2023
3 source controls mapped|3 target controls covered
27%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
3 source controls mapped|2 target controls covered
27%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
3 source controls mapped|5 target controls covered
27%
Serbia Law on Personal Data Protection (2018)
3 source controls mapped|3 target controls covered
27%
Lithuania Law on Legal Protection of Personal Data (2018)
3 source controls mapped|2 target controls covered
27%
Portugal Law No. 58/2019 - Data Protection Implementation Act
3 source controls mapped|4 target controls covered
27%
Netherlands GDPR Implementation Act (UAVG - Uitvoeringswet AVG, 2018)
3 source controls mapped|2 target controls covered
27%
Oman Personal Data Protection Law (Royal Decree 6/2022)
3 source controls mapped|2 target controls covered
27%
South Korea Personal Information Protection Act (PIPA)
3 source controls mapped|4 target controls covered
27%
NIST AI Risk Management Framework (AI RMF 1.0)
3 source controls mapped|4 target controls covered
27%
NIST AI 600-1: Generative AI Profile
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%
SQF Code Edition 9 - Safe Quality Food
3 source controls mapped|2 target controls covered
27%
21 CFR Part 211 - Current Good Manufacturing Practice
3 source controls mapped|2 target controls covered
27%
HKMA Cyber Resilience Assessment Framework (C-RAF)
3 source controls mapped|4 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%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
3 source controls mapped|5 target controls covered
27%
ASIS SPC.1-2009 - Organizational Resilience Standard
3 source controls mapped|2 target controls covered
27%
MITRE D3FEND
3 source controls mapped|2 target controls covered
27%
HL7 FHIR Security Framework
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%
OWASP ASVS
3 source controls mapped|2 target controls covered
27%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
2 source controls mapped|2 target controls covered
18%
New Zealand Information Security Manual (NZISM)
2 source controls mapped|2 target controls covered
18%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
2 source controls mapped|2 target controls covered
18%
South Korea Cloud Security Assurance Program (CSAP)
2 source controls mapped|2 target controls covered
18%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|2 target controls covered
18%
APRA CPS 230 Operational Risk Management
2 source controls mapped|3 target controls covered
18%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
2 source controls mapped|4 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%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
2 source controls mapped|5 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|3 target controls covered
18%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|3 target controls covered
18%
NAIC Insurance Data Security Model Law (MDL-668)
2 source controls mapped|3 target controls covered
18%
Modern Slavery Act 2018 (Australia)
2 source controls mapped|3 target controls covered
18%
ICH E6(R2) Good Clinical Practice - Data Integrity and Electronic Systems
2 source controls mapped|4 target controls covered
18%
Protective Security Policy Framework (PSPF) Release 2024
2 source controls mapped|1 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%
ISO 20000-1
2 source controls mapped|2 target controls covered
18%
ISO 14001
2 source controls mapped|1 target controls covered
18%
ISO 45001:2018
2 source controls mapped|1 target controls covered
18%
ISO 9001:2015
2 source controls mapped|2 target controls covered
18%
SWIFT CSCF
2 source controls mapped|2 target controls covered
18%
SWIFT CSCF v2024
2 source controls mapped|3 target controls covered
18%
ICAO Annex 17 - Aviation Security (AVSEC)
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%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
2 source controls mapped|2 target controls covered
18%
Science Based Targets initiative (SBTi) Corporate Standard
2 source controls mapped|2 target controls covered
18%
IEC 60601-1 - Medical Electrical Equipment Safety
2 source controls mapped|3 target controls covered
18%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 - CMA Directive)
2 source controls mapped|3 target controls covered
18%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
2 source controls mapped|2 target controls covered
18%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
2 source controls mapped|1 target controls covered
18%
Jordan Draft Personal Data Protection Law (2022)
2 source controls mapped|1 target controls covered
18%
LGPD
2 source controls mapped|1 target controls covered
18%
NIS2 Directive
2 source controls mapped|3 target controls covered
18%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|3 target controls covered
18%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
2 source controls mapped|2 target controls covered
18%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
2 source controls mapped|3 target controls covered
18%
Montenegro Law on Personal Data Protection (2023)
2 source controls mapped|3 target controls covered
18%
Law on Personal Data Protection (Official Gazette No. 42/2020)
2 source controls mapped|3 target controls covered
18%
Japan Act on Specified Commercial Transactions (ASCT) - Digital Services
2 source controls mapped|3 target controls covered
18%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
2 source controls mapped|3 target controls covered
18%
Uruguay Personal Data Protection Act (Law No. 18.331)
2 source controls mapped|3 target controls covered
18%
South Korea Credit Information Act
2 source controls mapped|1 target controls covered
18%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
2 source controls mapped|1 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%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
2 source controls mapped|2 target controls covered
18%
Wisconsin Data Privacy Act (SB 670)
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%
ISO 31000:2018
2 source controls mapped|1 target controls covered
18%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|3 target controls covered
18%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
18%
ISO 13485
2 source controls mapped|1 target controls covered
18%
ISO 13485:2016
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%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
2 source controls mapped|1 target controls covered
18%
Japan FSA Cybersecurity Guidelines for Financial Institutions
2 source controls mapped|1 target controls covered
18%
RBI Cybersecurity Framework for Banks
2 source controls mapped|1 target controls covered
18%
Kuwait National Cybersecurity Framework
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%
TNFD Recommendations
2 source controls mapped|1 target controls covered
18%
AASB S2 Climate-related Disclosures
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%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|1 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%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
2 source controls mapped|1 target controls covered
18%
Turkey Personal Data Protection Law (KVKK - Law No. 6698)
2 source controls mapped|1 target controls covered
18%
Uzbekistan Law on Personal Data (No. ZRU-547)
2 source controls mapped|1 target controls covered
18%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
2 source controls mapped|1 target controls covered
18%
Malta Data Protection Act (Cap. 586, 2018)
2 source controls mapped|1 target controls covered
18%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
2 source controls mapped|1 target controls covered
18%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
2 source controls mapped|1 target controls covered
18%
TEFCA - Trusted Exchange Framework and Common Agreement
2 source controls mapped|4 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%
IRS Publication 1075
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%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
18%
US Foreign Corrupt Practices Act (FCPA)
2 source controls mapped|1 target controls covered
18%
Regulation on the European Health Data Space (EHDS)
2 source controls mapped|4 target controls covered
18%
Florida Digital Bill of Rights (FDBR)
2 source controls mapped|1 target controls covered
18%
Saudi PDPL
2 source controls mapped|1 target controls covered
18%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|1 target controls covered
18%
ILO Nursing Personnel Convention C149 (1977)
2 source controls mapped|1 target controls covered
18%
IFRS 17 - Insurance Contracts
2 source controls mapped|1 target controls covered
18%
WCO Authorised Economic Operator (AEO) Framework
1 source controls mapped|2 target controls covered
9%
Authorised Economic Operator (AEO) Programmes - Global Standards
1 source controls mapped|2 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%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|2 target controls covered
9%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
1 source controls mapped|1 target controls covered
9%
Singapore Model AI Governance Framework (2nd Edition)
1 source controls mapped|2 target controls covered
9%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
1 source controls mapped|2 target controls covered
9%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
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%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|1 target controls covered
9%
Spain ENS
1 source controls mapped|4 target controls covered
9%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
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%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|3 target controls covered
9%
OWASP API Security Top 10 - 2023
1 source controls mapped|1 target controls covered
9%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
9%
ICH E6(R3) - Good Clinical Practice
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%
WELL Building Standard v2 (International WELL Building Institute)
1 source controls mapped|1 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 165 other compliance frameworks. The top mapping partners are Annex 11 to EU GMP - Computerised Systems (45% coverage), OWASP Top 10:2025 (36% coverage), Azure Security Benchmark (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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