Annex 11 to EU GMP - Computerised Systems

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.

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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
Code	Title	Description
Clause 1	Risk management	Risk assessment should be performed throughout the lifecycle to determine the level of validation and data integrity con...
Clause 2	Personnel	Requires appropriate qualifications, access levels and defined responsibilities for all personnel using computerised sys...
Clause 3	Suppliers and service providers	Formal agreements with third parties must establish well-defined responsibilities for computerised system services.

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
Code	Title	Description
Clause 10	Change and configuration management	All changes to computerised systems must follow defined change management procedures and be documented.
Clause 11	Periodic evaluation	Regular assessments of system functionality, deviations, incidents, security measures and validation status must be perf...

Operational Phase - Data Management

5 controls

Controls in the Operational Phase - Data Management domain of Annex 11 to EU GMP - Computerised Systems — 5 controls
Code	Title	Description
Clause 5	Data	Built-in checks must ensure correct and secure entry and processing of electronically exchanged data.
Clause 6	Accuracy checks	Critical manually entered data requires verification by a second operator or validated electronic means.
Clause 7	Data storage	Data must be protected through physical and electronic means with regular accessibility, readability and accuracy checks...
Clause 8	Printouts	Clear printed copies of stored data must be obtainable and must indicate whether data has been modified since original e...
Clause 9	Audit trails	Time-stamped audit trail records of all GMP-relevant changes and deletions must be maintained with documented reasons.

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
Code	Title	Description
Clause 15	Batch release	System access for batch release must be limited to Qualified Persons with required electronic signature identification.
Clause 16	Business continuity	Documented and tested procedures for alternative or manual operations must be maintained for system breakdowns.
Clause 17	Archiving	Periodic checks for accessibility, readability and integrity of archived data with retrieval capability after system cha...

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
Code	Title	Description
Clause 12	Security	Physical and logical access controls must restrict system use to authorised personnel only.
Clause 13	Incident management	All system failures and data errors must be reported, assessed, investigated and documented.
Clause 14	Electronic signatures	Electronic signatures must be equivalent to handwritten ones, permanently linked to records with date and time stamps.

Project Phase

1 controls

Controls in the Project Phase domain of Annex 11 to EU GMP - Computerised Systems — 1 controls
Code	Title	Description
Clause 4	Validation	Computerised systems must be validated throughout their lifecycle with documented protocols and user requirement specifi...

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 →

NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security

41%

7 controls mapped

Compare →

+ 295 more: GAMP 5 - Good Automated Manufacturing Practice (41%), FTC GLBA Safeguards Rule (16 CFR Part 314) (41%)

See all 298 mapped frameworks ↓

Maps to 298 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%

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%

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|3 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%

Azure Security Benchmark

6 source controls mapped|7 target controls covered

35%

AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)

6 source controls mapped|6 target controls covered

35%

AWS Well-Architected Security Pillar

6 source controls mapped|7 target controls covered

35%

ASIS SPC.1-2009 - Organizational Resilience Standard

6 source controls mapped|4 target controls covered

35%

APRA CPS 234

6 source controls mapped|10 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%

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%

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/IEC 29147:2018

5 source controls mapped|4 target controls covered

29%

NIST AI Risk Management Framework (AI RMF 1.0)

5 source controls mapped|9 target controls covered

29%

ISO/IEC 27011:2024

5 source controls mapped|7 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%

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%

ISO 41001:2018 - Facility Management Systems

5 source controls mapped|9 target controls covered

29%

ISO 39001:2012 - Road Traffic Safety Management

5 source controls mapped|9 target controls covered

29%

ISO 22313:2020 - Guidance on Business Continuity Management Systems

5 source controls mapped|9 target controls covered

29%

NIST Privacy Framework

5 source controls mapped|4 target controls covered

29%

NIS2 Directive

5 source controls mapped|5 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%

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%

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|2 target controls covered

24%

ISO/IEC 38500:2024 - Governance of IT

4 source controls mapped|4 target controls covered

24%

ISO/IEC 30111:2019

4 source controls mapped|4 target controls covered

24%

ISO/IEC 27557:2022 - Organisational Privacy Risk Management

4 source controls mapped|9 target controls covered

24%

ISO/IEC 23837 - Security Requirements for Quantum Key Distribution

4 source controls mapped|3 target controls covered

24%

ISO/IEC 29134:2023

4 source controls mapped|5 target controls covered

24%

ISO/IEC 27014:2020

4 source controls mapped|4 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 27400:2022

4 source controls mapped|5 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 17025:2017 - General Requirements for Testing and Calibration Laboratories

4 source controls mapped|5 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 20400:2017 - Sustainable Procurement

4 source controls mapped|6 target controls covered

24%

AS9100D - Aerospace Quality Management System

4 source controls mapped|8 target controls covered

24%

ISO/IEC 27003:2017

4 source controls mapped|8 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%

ISO 56002

4 source controls mapped|7 target controls covered

24%

ISO 37002:2021 - Whistleblowing Management Systems

4 source controls mapped|6 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|9 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%

NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)

4 source controls mapped|10 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|1 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%

NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity

3 source controls mapped|2 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|3 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%

21 CFR Part 211 - Current Good Manufacturing Practice

3 source controls mapped|2 target controls covered

18%

ISO/IEC 29100:2024

3 source controls mapped|3 target controls covered

18%

21 CFR Part 58 - Good Laboratory Practice (GLP)

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|3 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%

ISO/IEC 29115:2023 - Entity Authentication Assurance Framework

3 source controls mapped|1 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%

ISO/IEC 27050 - Electronic Discovery (Parts 1-4)

3 source controls mapped|1 target controls covered

18%

ISO/IEC 27006:2024

3 source controls mapped|4 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%

TISAX - Trusted Information Security Assessment Exchange

3 source controls mapped|3 target controls covered

18%

SASB Standards

3 source controls mapped|2 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%

FBI CJIS Security Policy

3 source controls mapped|3 target controls covered

18%

AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence

3 source controls mapped|5 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%

APPI

3 source controls mapped|4 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%

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%

ISO 22317

2 source controls mapped|3 target controls covered

12%

ISO 22318

2 source controls mapped|3 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%

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%

MARS-E - Minimum Acceptable Risk Standards for Exchanges

2 source controls mapped|1 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

SA8000:2014 - Social Accountability Standard

1 source controls mapped|1 target controls covered

OWASP Top 10 for LLM Applications 2025

1 source controls mapped|1 target controls covered

Modern Slavery Act 2018 (Australia)

1 source controls mapped|2 target controls covered

GS1 Global Standards - Supply Chain Traceability and Data Security

1 source controls mapped|2 target controls covered

BREEAM - Building Research Establishment Environmental Assessment Method

1 source controls mapped|1 target controls covered

ISO 26000:2010

1 source controls mapped|1 target controls covered

Space ISAC (Information Sharing and Analysis Center) - Threat Framework

1 source controls mapped|1 target controls covered

UNICEF Policy Guidance on AI for Children (2021)

1 source controls mapped|1 target controls covered

UNESCO Recommendation on the Ethics of AI

1 source controls mapped|1 target controls covered

UK AI Regulation Framework

1 source controls mapped|1 target controls covered

SEC Climate Disclosure Rule

1 source controls mapped|1 target controls covered

Own Risk and Solvency Assessment (ORSA) - NAIC Model Act

1 source controls mapped|2 target controls covered

OECD Recommendation on Artificial Intelligence (2024 Update)

1 source controls mapped|1 target controls covered

OECD AI Principles

1 source controls mapped|2 target controls covered

NIST SP 800-39

1 source controls mapped|3 target controls covered

NIST SP 800-37

1 source controls mapped|4 target controls covered

NIST SP 800-30

1 source controls mapped|6 target controls covered

New Zealand Information Security Manual (NZISM)

1 source controls mapped|2 target controls covered

Lloyd's of London Cyber Insurance Requirements and Underwriting Standards

1 source controls mapped|2 target controls covered

Japan AI Guidelines

1 source controls mapped|4 target controls covered

IEEE 7000

1 source controls mapped|2 target controls covered

ICMM Mining Principles (2024 Update)

1 source controls mapped|1 target controls covered

FSSC 22000 - Food Safety System Certification

1 source controls mapped|1 target controls covered

AML/CTF Act 2006 (Australia)

1 source controls mapped|2 target controls covered

Aged Care Quality Standards (Australia)

1 source controls mapped|1 target controls covered

ISO 31000

1 source controls mapped|6 target controls covered

ISO 22000

1 source controls mapped|1 target controls covered

ISO 45001

1 source controls mapped|1 target controls covered

APRA SPS 220 Risk Management (Superannuation)

1 source controls mapped|4 target controls covered

ISO 27005

1 source controls mapped|6 target controls covered

GDPR

1 source controls mapped|1 target controls covered

ISO 22301:2019

1 source controls mapped|3 target controls covered

Sigstore - Software Artifact Signing and Verification

1 source controls mapped|1 target controls covered

ITU-T X.805 - Security Architecture for End-to-End Communications

1 source controls mapped|1 target controls covered

Voluntary Principles on Security and Human Rights (VPs)

1 source controls mapped|1 target controls covered

Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)

1 source controls mapped|1 target controls covered

Laos Law on Prevention and Combating Cybercrime (2015)

1 source controls mapped|1 target controls covered

Japan FSA Cybersecurity Guidelines for Financial Institutions

1 source controls mapped|1 target controls covered

COSO Internal Control - Integrated Framework (2013)

1 source controls mapped|1 target controls covered

ISO 55001

1 source controls mapped|1 target controls covered

ISO 9001

1 source controls mapped|1 target controls covered

ISO 30401

1 source controls mapped|1 target controls covered

ISO 37001

1 source controls mapped|1 target controls covered

ISO 37301

1 source controls mapped|1 target controls covered

HL7 FHIR Security Framework

1 source controls mapped|2 target controls covered

GHG Protocol

1 source controls mapped|1 target controls covered

ISO/IEC 42001:2023

1 source controls mapped|5 target controls covered

ISO/IEC 38500:2024

1 source controls mapped|1 target controls covered

ISO/IEC TR 24028:2020

1 source controls mapped|4 target controls covered

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration

1 source controls mapped|1 target controls covered

Compare Annex 11 to EU GMP - Computerised Systems with FDA 21 CFR Part 11

Frequently Asked Questions

What is Annex 11 to EU GMP - Computerised Systems?

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.

How many controls does Annex 11 to EU GMP - Computerised Systems have?

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.

What frameworks does Annex 11 to EU GMP - Computerised Systems map to?

Annex 11 to EU GMP - Computerised Systems maps to 298 other compliance frameworks. The top mapping partners are FDA 21 CFR Part 11 (76% coverage), NIST SP 800-53 Rev 5 (53% coverage), NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security (41% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with Annex 11 to EU GMP - Computerised Systems compliance?

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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