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Annex 11 to EU GMP - Computerised Systems

Self-Assess
European Union (EMA/EC)
v2022
6 domains
17 controls

Annex 11 (revised 2022) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used throughout the pharmaceutical lifecycle, including manufacturing, quality control, laboratory testing, and distribution. It addresses system validation, data integrity, security, change control, backup and recovery, and the overall lifecycle management of computerised systems. Published by the European Commission as part of EudraLex Volume 4.

Verified

Annex 11 to EU GMP - Computerised Systems is a compliance framework from European Union (EMA/EC) with 6 domains and 17 controls that map to 314 other frameworks. The largest domains are Operational Phase - Data Management (5 controls), General Requirements (Annex 11) (3 controls), Operational Phase - Release and Continuity (3 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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 (6)

General Requirements (Annex 11)

3 controls
Controls in the General Requirements (Annex 11) domain of Annex 11 to EU GMP - Computerised Systems — 3 controls
CodeTitle
Clause 1Risk management
Clause 2Personnel
Clause 3Suppliers and service providers

Operational Phase - Change and Configuration

2 controls
Controls in the Operational Phase - Change and Configuration domain of Annex 11 to EU GMP - Computerised Systems — 2 controls
CodeTitle
Clause 10Change and configuration management
Clause 11Periodic evaluation

Operational Phase - Data Management

5 controls
Controls in the Operational Phase - Data Management domain of Annex 11 to EU GMP - Computerised Systems — 5 controls
CodeTitle
Clause 5Data
Clause 6Accuracy checks
Clause 7Data storage
Clause 8Printouts
Clause 9Audit trails

Operational Phase - Release and Continuity

3 controls
Controls in the Operational Phase - Release and Continuity domain of Annex 11 to EU GMP - Computerised Systems — 3 controls
CodeTitle
Clause 15Batch release
Clause 16Business continuity
Clause 17Archiving

Operational Phase - Security and Access

3 controls
Controls in the Operational Phase - Security and Access domain of Annex 11 to EU GMP - Computerised Systems — 3 controls
CodeTitle
Clause 12Security
Clause 13Incident management
Clause 14Electronic signatures

Project Phase

1 controls
Controls in the Project Phase domain of Annex 11 to EU GMP - Computerised Systems — 1 controls
CodeTitle
Clause 4Validation

Your Compliance Coverage

If you comply with Annex 11 to EU GMP - Computerised Systems, you already cover:

FDA 21 CFR Part 11

76%

13 controls mapped

Compare →

NIST SP 800-53 Rev 5

53%

9 controls mapped

Compare →

South Korea ISMS-P

47%

8 controls mapped

Compare →

+ 311 more: NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security (41%), GAMP 5 - Good Automated Manufacturing Practice (41%)

See all 314 mapped frameworks ↓

Maps to 314 other frameworks

17 total controls
FDA 21 CFR Part 11
13 source controls mapped|9 target controls covered
76%
NIST SP 800-53 Rev 5
9 source controls mapped|25 target controls covered
53%
South Korea ISMS-P
8 source controls mapped|9 target controls covered
47%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
7 source controls mapped|6 target controls covered
41%
GAMP 5 - Good Automated Manufacturing Practice
7 source controls mapped|5 target controls covered
41%
FTC GLBA Safeguards Rule (16 CFR Part 314)
7 source controls mapped|6 target controls covered
41%
FedRAMP Rev 5
7 source controls mapped|4 target controls covered
41%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
7 source controls mapped|13 target controls covered
41%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
7 source controls mapped|7 target controls covered
41%
ISO 28001:2007 Supply Chain Security Management
7 source controls mapped|5 target controls covered
41%
Protective Security Policy Framework (PSPF) Release 2024
6 source controls mapped|4 target controls covered
35%
PSD2 SCA
6 source controls mapped|4 target controls covered
35%
OWASP DevSecOps Maturity Model (DSOMM)
6 source controls mapped|4 target controls covered
35%
OSFI B-13
6 source controls mapped|5 target controls covered
35%
Open Banking Security
6 source controls mapped|5 target controls covered
35%
O-RAN WG11 Security Specification
6 source controls mapped|5 target controls covered
35%
NIST SP 800-146
6 source controls mapped|3 target controls covered
35%
NIST SP 800-145
6 source controls mapped|2 target controls covered
35%
NIST SP 800-144
6 source controls mapped|3 target controls covered
35%
Nigeria Data Protection Act 2023 (NDPA)
6 source controls mapped|5 target controls covered
35%
Nebraska Data Privacy Act
6 source controls mapped|5 target controls covered
35%
MTCS (Singapore)
6 source controls mapped|4 target controls covered
35%
Monetary Authority of Singapore Technology Risk Management Guidelines
6 source controls mapped|5 target controls covered
35%
South Korea PIPA
6 source controls mapped|4 target controls covered
35%
ISMAP (Japan)
6 source controls mapped|3 target controls covered
35%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
6 source controls mapped|6 target controls covered
35%
HKMA SPM
6 source controls mapped|3 target controls covered
35%
GLBA
6 source controls mapped|4 target controls covered
35%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
6 source controls mapped|6 target controls covered
35%
ASIS SPC.1-2009 - Organizational Resilience Standard
6 source controls mapped|4 target controls covered
35%
NIST SP 800-190
6 source controls mapped|7 target controls covered
35%
FFIEC IT Examination Handbook
6 source controls mapped|10 target controls covered
35%
PCI SSF
6 source controls mapped|10 target controls covered
35%
ISO 27018
6 source controls mapped|7 target controls covered
35%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
6 source controls mapped|7 target controls covered
35%
ISO 27017
6 source controls mapped|7 target controls covered
35%
PCI P2PE
6 source controls mapped|10 target controls covered
35%
PCI PIN Security
6 source controls mapped|10 target controls covered
35%
TISAX - Trusted Information Security Assessment Exchange
6 source controls mapped|8 target controls covered
35%
UK Gambling Commission - Cyber Resilience Requirements
5 source controls mapped|2 target controls covered
29%
UK GDPR (UK General Data Protection Regulation)
5 source controls mapped|2 target controls covered
29%
SLSA
5 source controls mapped|2 target controls covered
29%
SIG (Shared Assessments)
5 source controls mapped|3 target controls covered
29%
PTES
5 source controls mapped|3 target controls covered
29%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|5 target controls covered
29%
OWASP SAMM
5 source controls mapped|3 target controls covered
29%
OWASP MASVS
5 source controls mapped|2 target controls covered
29%
OpenSSF Scorecard
5 source controls mapped|3 target controls covered
29%
NIST SP 800-92
5 source controls mapped|3 target controls covered
29%
NIST SP 800-88
5 source controls mapped|2 target controls covered
29%
NIST SP 800-63-4
5 source controls mapped|3 target controls covered
29%
NIST SP 800-61
5 source controls mapped|3 target controls covered
29%
NIST SP 800-137
5 source controls mapped|3 target controls covered
29%
NIST SP 800-123
5 source controls mapped|3 target controls covered
29%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
5 source controls mapped|3 target controls covered
29%
MITRE D3FEND
5 source controls mapped|3 target controls covered
29%
MITRE ATT&CK
5 source controls mapped|4 target controls covered
29%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
5 source controls mapped|2 target controls covered
29%
ICH E6(R3) - Good Clinical Practice
5 source controls mapped|2 target controls covered
29%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|9 target controls covered
29%
IEC 62351 - Power Systems Communication Security
5 source controls mapped|3 target controls covered
29%
ISO/IEC 27031:2011
5 source controls mapped|4 target controls covered
29%
Barbados Data Protection Act 2019
5 source controls mapped|2 target controls covered
29%
ISO 27043
5 source controls mapped|5 target controls covered
29%
UK Telecommunications (Security) Act 2021
5 source controls mapped|4 target controls covered
29%
AICPA Privacy Management Framework (PMF)
5 source controls mapped|4 target controls covered
29%
ISO 22320:2018
5 source controls mapped|7 target controls covered
29%
SOC 2
5 source controls mapped|5 target controls covered
29%
SSAE 18 - Attestation Standards (SOC Reporting)
5 source controls mapped|9 target controls covered
29%
NIST Cybersecurity Framework 2.0
5 source controls mapped|13 target controls covered
29%
SANS Incident Handler's Handbook and PICERL Methodology
5 source controls mapped|5 target controls covered
29%
ISO/SAE 21434
5 source controls mapped|5 target controls covered
29%
ISO/IEC 23894:2023
5 source controls mapped|11 target controls covered
29%
NIST Privacy Framework
5 source controls mapped|4 target controls covered
29%
IEEE 1686
5 source controls mapped|4 target controls covered
29%
API 1164
5 source controls mapped|11 target controls covered
29%
IEC 62443
5 source controls mapped|11 target controls covered
29%
NIST SP 1800-32
5 source controls mapped|11 target controls covered
29%
ISO 27019
5 source controls mapped|11 target controls covered
29%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
5 source controls mapped|6 target controls covered
29%
Ghana Cybersecurity Act
5 source controls mapped|5 target controls covered
29%
FISMA
5 source controls mapped|3 target controls covered
29%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|7 target controls covered
29%
BSI IT-Grundschutz
5 source controls mapped|15 target controls covered
29%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
5 source controls mapped|8 target controls covered
29%
FATF Recommendation 16 - Virtual Asset Travel Rule
4 source controls mapped|1 target controls covered
24%
Trinidad and Tobago Data Protection Act 2011
4 source controls mapped|3 target controls covered
24%
Tanzania Personal Data Protection Act (Draft)
4 source controls mapped|2 target controls covered
24%
OWASP Top 10:2025
4 source controls mapped|1 target controls covered
24%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
4 source controls mapped|3 target controls covered
24%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
4 source controls mapped|6 target controls covered
24%
ICH Q10 - Pharmaceutical Quality System
4 source controls mapped|4 target controls covered
24%
IATF 16949:2016 - Quality Management System for Automotive Production
4 source controls mapped|5 target controls covered
24%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|2 target controls covered
24%
GLI-33 - Gaming Laboratories International Event Wagering Systems
4 source controls mapped|1 target controls covered
24%
French Sapin II Law (Law No. 2016-1691)
4 source controls mapped|3 target controls covered
24%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|3 target controls covered
24%
ISO/IEC 38500:2024 - Governance of IT
4 source controls mapped|4 target controls covered
24%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|6 target controls covered
24%
FedRAMP High
4 source controls mapped|3 target controls covered
24%
NIST SP 800-53 Revision 5.1 HIGH
4 source controls mapped|3 target controls covered
24%
FedRAMP Moderate
4 source controls mapped|3 target controls covered
24%
NIST SP 800-53 Rev 5 MODERATE
4 source controls mapped|3 target controls covered
24%
NIST SP 800-53 Rev 5 LOW
4 source controls mapped|3 target controls covered
24%
ISO/IEC 29147:2018
4 source controls mapped|2 target controls covered
24%
IEC 60601-1 - Medical Electrical Equipment Safety
4 source controls mapped|4 target controls covered
24%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
4 source controls mapped|3 target controls covered
24%
ISO/IEC 30111:2019
4 source controls mapped|2 target controls covered
24%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
4 source controls mapped|4 target controls covered
24%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|8 target controls covered
24%
ISO 37000:2021 - Governance of Organizations
4 source controls mapped|4 target controls covered
24%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
4 source controls mapped|3 target controls covered
24%
Kuwait National Cybersecurity Framework
4 source controls mapped|2 target controls covered
24%
ISO 20400:2017 - Sustainable Procurement
4 source controls mapped|6 target controls covered
24%
ISO/IEC 27003:2017
4 source controls mapped|6 target controls covered
24%
ISO/IEC 25012:2008 - Data Quality Model
4 source controls mapped|3 target controls covered
24%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|5 target controls covered
24%
Singapore Cybersecurity Act 2018
4 source controls mapped|2 target controls covered
24%
UK Open Banking Standard
4 source controls mapped|2 target controls covered
24%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
24%
ISO 26262:2018 - Functional Safety for Road Vehicles
4 source controls mapped|4 target controls covered
24%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
4 source controls mapped|3 target controls covered
24%
NERC CIP
4 source controls mapped|3 target controls covered
24%
APRA CPS 230 Operational Risk Management
4 source controls mapped|8 target controls covered
24%
ISO/IEC 27010:2015
4 source controls mapped|5 target controls covered
24%
TSA Pipeline Cybersecurity Directives
4 source controls mapped|2 target controls covered
24%
NIS2 Directive Implementing Acts
4 source controls mapped|3 target controls covered
24%
Oman National Cybersecurity Framework
4 source controls mapped|4 target controls covered
24%
WCAG 2.2
3 source controls mapped|1 target controls covered
18%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|1 target controls covered
18%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
3 source controls mapped|1 target controls covered
18%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
18%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|1 target controls covered
18%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
18%
Notifiable Data Breaches Scheme (Australia)
3 source controls mapped|1 target controls covered
18%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|1 target controls covered
18%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
3 source controls mapped|2 target controls covered
18%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
18%
ITAR - International Traffic in Arms Regulations
3 source controls mapped|1 target controls covered
18%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|2 target controls covered
18%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|2 target controls covered
18%
ISO/IEC 27004:2016
3 source controls mapped|2 target controls covered
18%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|2 target controls covered
18%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|4 target controls covered
18%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|1 target controls covered
18%
ISO 19011
3 source controls mapped|3 target controls covered
18%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
18%
COBIT 2019
3 source controls mapped|1 target controls covered
18%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
18%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
3 source controls mapped|2 target controls covered
18%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
18%
ISO 31000:2018
3 source controls mapped|1 target controls covered
18%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
18%
PCI DSS 4.0
3 source controls mapped|1 target controls covered
18%
ISO/IEC 29100:2024
3 source controls mapped|1 target controls covered
18%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
3 source controls mapped|4 target controls covered
18%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
18%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
18%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
3 source controls mapped|1 target controls covered
18%
ISO 8000 - Data Quality
3 source controls mapped|2 target controls covered
18%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
18%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
18%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|2 target controls covered
18%
ISO 56002
3 source controls mapped|2 target controls covered
18%
ISO 41001:2018 - Facility Management Systems
3 source controls mapped|3 target controls covered
18%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|1 target controls covered
18%
SASB Standards
3 source controls mapped|7 target controls covered
18%
ICAO Annex 17 - Aviation Security (AVSEC)
3 source controls mapped|2 target controls covered
18%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
3 source controls mapped|1 target controls covered
18%
ISO/IEC 27011:2024
3 source controls mapped|4 target controls covered
18%
FBI CJIS Security Policy
3 source controls mapped|3 target controls covered
18%
AS9100D - Aerospace Quality Management System
3 source controls mapped|2 target controls covered
18%
Sigstore - Software Artifact Signing and Verification
3 source controls mapped|3 target controls covered
18%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|8 target controls covered
18%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
3 source controls mapped|3 target controls covered
18%
Virginia CDPA
3 source controls mapped|1 target controls covered
18%
Vietnam PDPD
3 source controls mapped|2 target controls covered
18%
Uruguay DPL
3 source controls mapped|3 target controls covered
18%
Turkey KVKK
3 source controls mapped|2 target controls covered
18%
Texas Data Privacy Act
3 source controls mapped|2 target controls covered
18%
Taiwan PDPA
3 source controls mapped|1 target controls covered
18%
Qatar DPL
3 source controls mapped|3 target controls covered
18%
Privacy Act 2020
3 source controls mapped|3 target controls covered
18%
POPIA
3 source controls mapped|2 target controls covered
18%
Personal Data Act (personopplysningsloven)
3 source controls mapped|3 target controls covered
18%
PDPA Thailand
3 source controls mapped|3 target controls covered
18%
PDPA Singapore
3 source controls mapped|3 target controls covered
18%
Oregon Consumer Privacy Act
3 source controls mapped|2 target controls covered
18%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|3 target controls covered
18%
NIST SP 800-66
3 source controls mapped|4 target controls covered
18%
NIST SP 800-122
3 source controls mapped|3 target controls covered
18%
Nigeria Data Protection Regulation (NDPR)
3 source controls mapped|1 target controls covered
18%
New Jersey Data Privacy Act
3 source controls mapped|3 target controls covered
18%
New Hampshire Data Privacy Act
3 source controls mapped|2 target controls covered
18%
Nevada Gaming Control Board Cybersecurity Requirements
3 source controls mapped|4 target controls covered
18%
NAIC Insurance Data Security Model Law (MDL-668)
3 source controls mapped|2 target controls covered
18%
Montana Consumer Data Privacy Act
3 source controls mapped|2 target controls covered
18%
Minnesota Consumer Data Privacy Act
3 source controls mapped|2 target controls covered
18%
Mexico LFPDPPP
3 source controls mapped|2 target controls covered
18%
MDS2 (Medical Device)
3 source controls mapped|4 target controls covered
18%
Mauritius DPA
3 source controls mapped|2 target controls covered
18%
Maryland Online Data Privacy Act of 2024
3 source controls mapped|3 target controls covered
18%
MARS-E
3 source controls mapped|6 target controls covered
18%
Malaysia PDPA 2010
3 source controls mapped|3 target controls covered
18%
Liechtenstein DPA
3 source controls mapped|2 target controls covered
18%
LGPD
3 source controls mapped|2 target controls covered
18%
Ley Orgánica de Protección de Datos Personales (LOPDP)
3 source controls mapped|2 target controls covered
18%
Law No. 172-13 on the Protection of Personal Data
3 source controls mapped|2 target controls covered
18%
Kentucky Consumer Data Protection Act
3 source controls mapped|3 target controls covered
18%
Jamaica Data Protection Act 2020
3 source controls mapped|4 target controls covered
18%
Iowa Consumer Data Protection Act
3 source controls mapped|4 target controls covered
18%
Indonesia PDP Law
3 source controls mapped|4 target controls covered
18%
Indiana Consumer Data Protection Act
3 source controls mapped|2 target controls covered
18%
India DPDP Act
3 source controls mapped|2 target controls covered
18%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
3 source controls mapped|1 target controls covered
18%
Family Educational Rights and Privacy Act (FERPA)
3 source controls mapped|1 target controls covered
18%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
3 source controls mapped|3 target controls covered
18%
Bahrain PDPL
3 source controls mapped|4 target controls covered
18%
ISO 27799
3 source controls mapped|5 target controls covered
18%
ISO 13485
3 source controls mapped|5 target controls covered
18%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
3 source controls mapped|5 target controls covered
18%
Saudi Arabia PDPL
3 source controls mapped|4 target controls covered
18%
ASD Strategies to Mitigate Cyber Security Incidents
3 source controls mapped|6 target controls covered
18%
HITECH Act
3 source controls mapped|2 target controls covered
18%
Canada ITSG-33 - IT Security Risk Management
3 source controls mapped|1 target controls covered
18%
ITIL 4
3 source controls mapped|4 target controls covered
18%
ISO 20000-1
3 source controls mapped|4 target controls covered
18%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|2 target controls covered
12%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
2 source controls mapped|1 target controls covered
12%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
2 source controls mapped|2 target controls covered
12%
German Supply Chain Due Diligence Act (LkSG)
2 source controls mapped|3 target controls covered
12%
Authorised Economic Operator (AEO) Programmes - Global Standards
2 source controls mapped|5 target controls covered
12%
SQF Code Edition 9 - Safe Quality Food
2 source controls mapped|2 target controls covered
12%
Solvency II
2 source controls mapped|4 target controls covered
12%
ISO 22317
2 source controls mapped|3 target controls covered
12%
ISO 22318
2 source controls mapped|3 target controls covered
12%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
2 source controls mapped|6 target controls covered
12%
ISO 22316
2 source controls mapped|3 target controls covered
12%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
2 source controls mapped|2 target controls covered
12%
India CERT-In Cyber Security Directions 2022
2 source controls mapped|1 target controls covered
12%
BS 65000:2014 - Guidance on Organizational Resilience
2 source controls mapped|2 target controls covered
12%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
2 source controls mapped|2 target controls covered
12%
APRA CPS 234
2 source controls mapped|4 target controls covered
12%
Telecommunications Sector Security Reforms (TSSR)
2 source controls mapped|2 target controls covered
12%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
2 source controls mapped|4 target controls covered
12%
EASA Part-IS - Information Security in Aviation
2 source controls mapped|8 target controls covered
12%
FIRST CSIRT Services Framework and Standards
2 source controls mapped|1 target controls covered
12%
ISO 27002:2022
2 source controls mapped|4 target controls covered
12%
Peru DPL
2 source controls mapped|2 target controls covered
12%
APPI
2 source controls mapped|3 target controls covered
12%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
2 source controls mapped|1 target controls covered
12%
ISO/IEC 27400:2022
2 source controls mapped|2 target controls covered
12%
NIST SP 800-171
2 source controls mapped|2 target controls covered
12%
Secure by Design: A Guide for Manufacturers (CISA)
2 source controls mapped|1 target controls covered
12%
ISO 10006:2003
1 source controls mapped|1 target controls covered
6%
SA8000:2014 - Social Accountability Standard
1 source controls mapped|1 target controls covered
6%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
6%
Modern Slavery Act 2018 (Australia)
1 source controls mapped|2 target controls covered
6%
GS1 Global Standards - Supply Chain Traceability and Data Security
1 source controls mapped|2 target controls covered
6%
21 CFR Part 211 - Current Good Manufacturing Practice
1 source controls mapped|1 target controls covered
6%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
6%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
6%
ISO 26000:2010
1 source controls mapped|1 target controls covered
6%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
6%
ISO 50001:2018 - Energy Management Systems
1 source controls mapped|1 target controls covered
6%
UNICEF Policy Guidance on AI for Children (2021)
1 source controls mapped|1 target controls covered
6%
UNESCO Recommendation on the Ethics of AI
1 source controls mapped|2 target controls covered
6%
UK AI Regulation Framework
1 source controls mapped|1 target controls covered
6%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
6%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|2 target controls covered
6%
OECD Recommendation on Artificial Intelligence (2024 Update)
1 source controls mapped|1 target controls covered
6%
OECD AI Principles
1 source controls mapped|2 target controls covered
6%
NIST SP 800-39
1 source controls mapped|3 target controls covered
6%
NIST SP 800-37
1 source controls mapped|4 target controls covered
6%
NIST SP 800-30
1 source controls mapped|6 target controls covered
6%
New Zealand Information Security Manual (NZISM)
1 source controls mapped|2 target controls covered
6%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
6%
Japan AI Guidelines
1 source controls mapped|4 target controls covered
6%
IEEE 7000
1 source controls mapped|2 target controls covered
6%
ICMM Mining Principles (2024 Update)
1 source controls mapped|1 target controls covered
6%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|1 target controls covered
6%
Singapore AI Governance Framework
1 source controls mapped|1 target controls covered
6%
AML/CTF Act 2006 (Australia)
1 source controls mapped|2 target controls covered
6%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|3 target controls covered
6%
ISO/IEC 29134:2023
1 source controls mapped|1 target controls covered
6%
Aged Care Quality Standards 2019 (repealed edition)
1 source controls mapped|1 target controls covered
6%
UK Modern Slavery Act 2015
1 source controls mapped|1 target controls covered
6%
ISO 31000
1 source controls mapped|6 target controls covered
6%
ISO 22000
1 source controls mapped|1 target controls covered
6%
ISO 45001
1 source controls mapped|1 target controls covered
6%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|2 target controls covered
6%
ISO 27005
1 source controls mapped|6 target controls covered
6%
UK Age Appropriate Design Code (Children's Code)
1 source controls mapped|1 target controls covered
6%
GDPR
1 source controls mapped|1 target controls covered
6%
ISO 22301:2019
1 source controls mapped|3 target controls covered
6%
ITU-T X.805 - Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
6%
US ITAR and EAR - Export Control and Data Security
1 source controls mapped|1 target controls covered
6%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
6%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|1 target controls covered
6%
Laos Law on Prevention and Combating Cybercrime (2015)
1 source controls mapped|1 target controls covered
6%
Japan FSA Cybersecurity Guidelines for Financial Institutions
1 source controls mapped|1 target controls covered
6%
COSO Internal Control - Integrated Framework (2013)
1 source controls mapped|1 target controls covered
6%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|1 target controls covered
6%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
1 source controls mapped|2 target controls covered
6%
ISO 55001
1 source controls mapped|1 target controls covered
6%
ISO 9001
1 source controls mapped|1 target controls covered
6%
ISO 30401
1 source controls mapped|1 target controls covered
6%
ISO 37001
1 source controls mapped|1 target controls covered
6%
ISO 37301
1 source controls mapped|1 target controls covered
6%
HL7 FHIR Security Framework
1 source controls mapped|2 target controls covered
6%
GHG Protocol
1 source controls mapped|1 target controls covered
6%
ISO/IEC 42001:2023
1 source controls mapped|3 target controls covered
6%
ISO/IEC 38500:2024
1 source controls mapped|1 target controls covered
6%
ISO/IEC TR 24028:2020
1 source controls mapped|4 target controls covered
6%
Compare Annex 11 to EU GMP - Computerised Systems with FDA 21 CFR Part 11

What is Annex 11 to EU GMP - Computerised Systems and who does it apply to?

Annex 11 to EU GMP - Computerised Systems is a compliance framework from European Union (EMA/EC) with 6 domains and 17 controls. Annex 11 (revised 2022) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used throughout the pharmaceutical lifecycle, including manufacturing, quality control, laboratory testing, and distribution. It addresses system validation, data integrity, security, change control, backup and recovery, and the overall lifecycle management of computerised systems. Published by the European Commission as part of EudraLex Volume 4. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does Annex 11 to EU GMP - Computerised Systems actually require?

Annex 11 to EU GMP - Computerised Systems has 17 controls organised across 6 domains. The largest domains are Operational Phase - Data Management (5 controls), General Requirements (Annex 11) (3 controls), Operational Phase - Release and Continuity (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of Annex 11 to EU GMP - Computerised Systems do I already cover?

Annex 11 to EU GMP - Computerised Systems maps to 314 other compliance frameworks. The top mapping partners are FDA 21 CFR Part 11 (76% coverage), NIST SP 800-53 Rev 5 (53% coverage), South Korea ISMS-P (47% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement Annex 11 to EU GMP - Computerised Systems?

Start your Annex 11 to EU GMP - Computerised Systems compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about Annex 11 to EU GMP - Computerised Systems 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 17 controls and track your progress.

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