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EU GMP Annex 11 — Computerised Systems

Self-Assess
European Union (EMA/EC)
v2011 (revised)
6 domains
23 controls

EU GMP Annex 11 (revised 2011) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in pharmaceutical manufacturing and quality control. Published by the European Commission as part of EudraLex Volume 4. Covers the complete lifecycle of computerised systems from specification through decommissioning. Key topics include risk management, validation, data integrity, electronic signatures, batch release, and cloud computing. Applicable to all computerised systems used in GMP-regulated activities.

Verified

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

9 controls

Six general requirements that apply across all four pillars

Controls in the General Requirements domain of EU GMP Annex 11 — Computerised Systems — 9 controls
CodeTitle
Clause 1Risk management
Clause 2Personnel
Clause 3Suppliers and service providers
TNFD-GR-1Materiality
TNFD-GR-2Scope of Disclosures
TNFD-GR-3Location of Nature-related Issues
TNFD-GR-4Integration with Other Sustainability Disclosures
TNFD-GR-5Time Horizons
TNFD-GR-6Engagement with Affected Stakeholders

Operational Phase — Change and Configuration

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

Project Phase

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

Maps to 631 other frameworks

23 total controls
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
8 source controls mapped|10 target controls covered
35%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
8 source controls mapped|14 target controls covered
35%
ASIC Cyber Resilience Good Practices
8 source controls mapped|9 target controls covered
35%
CSA STAR (Security, Trust, Assurance, and Risk)
8 source controls mapped|7 target controls covered
35%
FTC GLBA Safeguards Rule (16 CFR Part 314)
8 source controls mapped|12 target controls covered
35%
South Korea ISMS-P
8 source controls mapped|9 target controls covered
35%
ASD Information Security Manual (ISM)
8 source controls mapped|20 target controls covered
35%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
8 source controls mapped|11 target controls covered
35%
Canada ITSG-33 — IT Security Risk Management
8 source controls mapped|11 target controls covered
35%
New Zealand Information Security Manual (NZISM)
8 source controls mapped|11 target controls covered
35%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
8 source controls mapped|11 target controls covered
35%
South Korea Cloud Security Assurance Program (CSAP)
8 source controls mapped|12 target controls covered
35%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
8 source controls mapped|13 target controls covered
35%
Defence Security Principles Framework (DSPF)
8 source controls mapped|23 target controls covered
35%
Protective Security Policy Framework (PSPF) Release 2024
8 source controls mapped|24 target controls covered
35%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
7 source controls mapped|12 target controls covered
30%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
7 source controls mapped|8 target controls covered
30%
CSA CCM v4
7 source controls mapped|22 target controls covered
30%
ISO 28001:2007 Supply Chain Security Management
7 source controls mapped|9 target controls covered
30%
EIOPA Guidelines on ICT Security and Governance (2020)
7 source controls mapped|14 target controls covered
30%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
7 source controls mapped|10 target controls covered
30%
NIS2 Directive Implementing Acts
7 source controls mapped|17 target controls covered
30%
FAA Cybersecurity Framework for Aviation
7 source controls mapped|18 target controls covered
30%
RBI Cybersecurity Framework for Banks
7 source controls mapped|10 target controls covered
30%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
7 source controls mapped|13 target controls covered
30%
FedRAMP Rev 5
7 source controls mapped|21 target controls covered
30%
OWASP Top 10:2025
7 source controls mapped|7 target controls covered
30%
TISAX — Trusted Information Security Assessment Exchange
7 source controls mapped|14 target controls covered
30%
Telecommunications Sector Security Reforms (TSSR)
7 source controls mapped|10 target controls covered
30%
NIST SP 800-82 Rev 3 — Guide to OT Security
7 source controls mapped|11 target controls covered
30%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
6 source controls mapped|9 target controls covered
26%
BCBS 239
6 source controls mapped|10 target controls covered
26%
APRA CPS 234
6 source controls mapped|10 target controls covered
26%
ASIS SPC.1-2009 — Organizational Resilience Standard
6 source controls mapped|4 target controls covered
26%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
6 source controls mapped|12 target controls covered
26%
PCI SSF
6 source controls mapped|10 target controls covered
26%
FTC Safeguards Rule (16 CFR Part 314)
6 source controls mapped|12 target controls covered
26%
ECB TIBER-EU
6 source controls mapped|10 target controls covered
26%
SWIFT CSCF
6 source controls mapped|10 target controls covered
26%
MAS TRM
6 source controls mapped|10 target controls covered
26%
HKMA SPM
6 source controls mapped|10 target controls covered
26%
AICPA SOC 1
6 source controls mapped|10 target controls covered
26%
PCI P2PE
6 source controls mapped|10 target controls covered
26%
DORA
6 source controls mapped|10 target controls covered
26%
FFIEC IT Examination Handbook
6 source controls mapped|10 target controls covered
26%
PCI PIN Security
6 source controls mapped|10 target controls covered
26%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
6 source controls mapped|9 target controls covered
26%
Japan FSA Cybersecurity Guidelines for Financial Institutions
6 source controls mapped|10 target controls covered
26%
Kuwait National Cybersecurity Framework
6 source controls mapped|9 target controls covered
26%
SWIFT CSP
6 source controls mapped|10 target controls covered
26%
GLBA
6 source controls mapped|10 target controls covered
26%
OSFI B-13
6 source controls mapped|10 target controls covered
26%
Open Banking Security
6 source controls mapped|10 target controls covered
26%
AICPA SOC 3
6 source controls mapped|10 target controls covered
26%
PSD2 SCA
6 source controls mapped|10 target controls covered
26%
ISO 27001:2022
6 source controls mapped|12 target controls covered
26%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
6 source controls mapped|10 target controls covered
26%
UK Telecommunications (Security) Act 2021
6 source controls mapped|16 target controls covered
26%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
6 source controls mapped|10 target controls covered
26%
HKMA Cyber Resilience Assessment Framework (C-RAF)
6 source controls mapped|9 target controls covered
26%
Australian Energy Sector Cyber Security Framework (AESCSF)
6 source controls mapped|17 target controls covered
26%
NAIC Insurance Data Security Model Law (MDL-668)
6 source controls mapped|11 target controls covered
26%
OWASP DevSecOps Maturity Model (DSOMM)
6 source controls mapped|9 target controls covered
26%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
6 source controls mapped|4 target controls covered
26%
GLI-33 — Gaming Laboratories International Event Wagering Systems
6 source controls mapped|10 target controls covered
26%
PCI DSS v4.0
6 source controls mapped|12 target controls covered
26%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
6 source controls mapped|9 target controls covered
26%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
6 source controls mapped|7 target controls covered
26%
NIST SP 800-53 Rev 5
6 source controls mapped|19 target controls covered
26%
SWIFT Customer Security Programme (CSP)
6 source controls mapped|6 target controls covered
26%
South Korea PIPA
6 source controls mapped|5 target controls covered
26%
US ITAR and EAR — Export Control and Data Security
6 source controls mapped|8 target controls covered
26%
UK Gambling Commission — Cyber Resilience Requirements
6 source controls mapped|9 target controls covered
26%
O-RAN Alliance Security Specifications (O-RAN.WG11)
6 source controls mapped|6 target controls covered
26%
NIST AI Risk Management Framework (AI RMF 1.0)
6 source controls mapped|11 target controls covered
26%
NIST AI 600-1 Generative AI Profile
6 source controls mapped|12 target controls covered
26%
CAIQ (CSA)
6 source controls mapped|7 target controls covered
26%
AWS Well-Architected Security Pillar
6 source controls mapped|7 target controls covered
26%
Azure Security Benchmark
6 source controls mapped|7 target controls covered
26%
C5 (Germany)
6 source controls mapped|7 target controls covered
26%
ISO 27018
6 source controls mapped|7 target controls covered
26%
NIST SP 800-190
6 source controls mapped|7 target controls covered
26%
NIST SP 800-145
6 source controls mapped|7 target controls covered
26%
ISMAP (Japan)
6 source controls mapped|7 target controls covered
26%
MTCS (Singapore)
6 source controls mapped|7 target controls covered
26%
BREEAM — Building Research Establishment Environmental Assessment Method
6 source controls mapped|7 target controls covered
26%
AICPA Privacy Management Framework (PMF)
6 source controls mapped|5 target controls covered
26%
NIST SP 800-146
6 source controls mapped|7 target controls covered
26%
NIST SP 800-144
6 source controls mapped|7 target controls covered
26%
ISO 27017
6 source controls mapped|7 target controls covered
26%
ISO/IEC 27031:2011
5 source controls mapped|4 target controls covered
22%
BS 65000:2014 — Guidance on Organizational Resilience
5 source controls mapped|5 target controls covered
22%
EU NIS2 Directive — Transport Sector Requirements
5 source controls mapped|5 target controls covered
22%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
5 source controls mapped|12 target controls covered
22%
Oman National Cybersecurity Framework
5 source controls mapped|8 target controls covered
22%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
5 source controls mapped|8 target controls covered
22%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|6 target controls covered
22%
ISO 41001:2018 — Facility Management Systems
5 source controls mapped|9 target controls covered
22%
ISO 39001:2012 — Road Traffic Safety Management
5 source controls mapped|9 target controls covered
22%
ISO 50001:2018 — Energy Management Systems
5 source controls mapped|9 target controls covered
22%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
5 source controls mapped|9 target controls covered
22%
CISA Zero Trust Maturity Model
5 source controls mapped|16 target controls covered
22%
Cyber Essentials Plus
5 source controls mapped|16 target controls covered
22%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
5 source controls mapped|14 target controls covered
22%
BSIMM
5 source controls mapped|5 target controls covered
22%
BSI IT-Grundschutz
5 source controls mapped|15 target controls covered
22%
IEC 62351 — Power Systems Communication Security
5 source controls mapped|3 target controls covered
22%
California IoT Security Law
5 source controls mapped|5 target controls covered
22%
API 1164
5 source controls mapped|11 target controls covered
22%
OWASP ASVS
5 source controls mapped|5 target controls covered
22%
C2M2
5 source controls mapped|11 target controls covered
22%
Belgium CyberFundamentals
5 source controls mapped|16 target controls covered
22%
CMMC 2.0
5 source controls mapped|16 target controls covered
22%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|7 target controls covered
22%
3GPP Security
5 source controls mapped|5 target controls covered
22%
ISO/IEC 27011:2024
5 source controls mapped|7 target controls covered
22%
ANSSI Cybersecurity Framework
5 source controls mapped|16 target controls covered
22%
BIMCO Cyber Security
5 source controls mapped|11 target controls covered
22%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
5 source controls mapped|11 target controls covered
22%
HL7 FHIR Security Framework
5 source controls mapped|7 target controls covered
22%
NIST SP 800-88
5 source controls mapped|5 target controls covered
22%
NIST SP 800-61
5 source controls mapped|5 target controls covered
22%
NIST SP 800-171
5 source controls mapped|16 target controls covered
22%
NIST SP 800-53A
5 source controls mapped|15 target controls covered
22%
DO-326A
5 source controls mapped|11 target controls covered
22%
EU Cyber Resilience Act
5 source controls mapped|5 target controls covered
22%
IEEE 1686
5 source controls mapped|11 target controls covered
22%
NIST SP 800-187
5 source controls mapped|5 target controls covered
22%
UNECE WP.29 R155
5 source controls mapped|5 target controls covered
22%
NIST SP 1800-32
5 source controls mapped|11 target controls covered
22%
Ghana Cybersecurity Act
5 source controls mapped|15 target controls covered
22%
NIST SP 800-160
5 source controls mapped|5 target controls covered
22%
NIST SP 800-181
5 source controls mapped|5 target controls covered
22%
NIST SP 800-207
5 source controls mapped|5 target controls covered
22%
OWASP SAMM
5 source controls mapped|5 target controls covered
22%
ISO 27043
5 source controls mapped|5 target controls covered
22%
NIST SP 800-172
5 source controls mapped|15 target controls covered
22%
Spain ENS
5 source controls mapped|16 target controls covered
22%
ISO/SAE 21434
5 source controls mapped|5 target controls covered
22%
OWASP MASVS
5 source controls mapped|5 target controls covered
22%
NIS2 Directive
5 source controls mapped|12 target controls covered
22%
ISO 27019
5 source controls mapped|11 target controls covered
22%
NIST SP 800-218
5 source controls mapped|5 target controls covered
22%
NIST SP 800-150
5 source controls mapped|5 target controls covered
22%
SSDF (NIST)
5 source controls mapped|5 target controls covered
22%
FBI CJIS Security Policy
5 source controls mapped|8 target controls covered
22%
PTES
5 source controls mapped|5 target controls covered
22%
SIG (Shared Assessments)
5 source controls mapped|5 target controls covered
22%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
5 source controls mapped|3 target controls covered
22%
NIST SP 800-128
5 source controls mapped|5 target controls covered
22%
NIST SP 800-183
5 source controls mapped|5 target controls covered
22%
UNECE WP.29 R156
5 source controls mapped|5 target controls covered
22%
MITRE D3FEND
5 source controls mapped|5 target controls covered
22%
NIST SP 800-63
5 source controls mapped|5 target controls covered
22%
SLSA
5 source controls mapped|5 target controls covered
22%
IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems
5 source controls mapped|6 target controls covered
22%
ETSI EN 303 645
5 source controls mapped|5 target controls covered
22%
NIST SP 800-92
5 source controls mapped|5 target controls covered
22%
SOC 2
5 source controls mapped|5 target controls covered
22%
NIST SP 800-137
5 source controls mapped|5 target controls covered
22%
UK PSTI Act
5 source controls mapped|5 target controls covered
22%
DoD Zero Trust Reference Architecture
5 source controls mapped|16 target controls covered
22%
ISO 27002:2022
5 source controls mapped|5 target controls covered
22%
NIST Privacy Framework 1.0
5 source controls mapped|10 target controls covered
22%
NIST SP 800-123
5 source controls mapped|5 target controls covered
22%
MITRE ATT&CK
5 source controls mapped|5 target controls covered
22%
IEC 62443
5 source controls mapped|11 target controls covered
22%
NIST SP 800-161
5 source controls mapped|5 target controls covered
22%
TSA Pipeline Security
5 source controls mapped|12 target controls covered
22%
OpenSSF Scorecard
5 source controls mapped|5 target controls covered
22%
FISMA
5 source controls mapped|16 target controls covered
22%
IRS Publication 1075 — Tax Information Security Guidelines
5 source controls mapped|3 target controls covered
22%
NIST SP 800-115
5 source controls mapped|5 target controls covered
22%
Saudi NCA ECC
5 source controls mapped|15 target controls covered
22%
TEFCA — Trusted Exchange Framework and Common Agreement
5 source controls mapped|3 target controls covered
22%
Singapore Cybersecurity Act 2018
5 source controls mapped|3 target controls covered
22%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
5 source controls mapped|7 target controls covered
22%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
5 source controls mapped|6 target controls covered
22%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
5 source controls mapped|6 target controls covered
22%
Australia Consumer Data Right — Banking (CDR)
5 source controls mapped|8 target controls covered
22%
Barbados Data Protection Act 2019
5 source controls mapped|2 target controls covered
22%
ISO/IEC 29147:2018
5 source controls mapped|4 target controls covered
22%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
5 source controls mapped|8 target controls covered
22%
Chile Personal Data Protection Law (Law No. 21.719)
5 source controls mapped|5 target controls covered
22%
SSAE 18 — Attestation Standards (SOC Reporting)
5 source controls mapped|9 target controls covered
22%
MTCS — Multi-Tier Cloud Security (Singapore)
5 source controls mapped|3 target controls covered
22%
ISO 22320:2018
5 source controls mapped|7 target controls covered
22%
Notifiable Data Breaches Scheme (Australia)
5 source controls mapped|8 target controls covered
22%
EU Digital Markets Act
5 source controls mapped|7 target controls covered
22%
FTC Health Breach Notification Rule
5 source controls mapped|9 target controls covered
22%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
5 source controls mapped|7 target controls covered
22%
EAR — Export Administration Regulations
5 source controls mapped|7 target controls covered
22%
European Accessibility Act (Directive (EU) 2019/882)
5 source controls mapped|7 target controls covered
22%
EU Deforestation-Free Products Regulation (EUDR)
5 source controls mapped|7 target controls covered
22%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
5 source controls mapped|8 target controls covered
22%
US SEC Digital Assets and Crypto Regulatory Framework
5 source controls mapped|9 target controls covered
22%
Australia eSafety Commissioner — Online Safety Expectations for Industry
5 source controls mapped|7 target controls covered
22%
Trinidad and Tobago Data Protection Act 2011
5 source controls mapped|5 target controls covered
22%
NIST Cybersecurity Framework 2.0
5 source controls mapped|13 target controls covered
22%
UK GDPR (UK General Data Protection Regulation)
5 source controls mapped|3 target controls covered
22%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
5 source controls mapped|3 target controls covered
22%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
5 source controls mapped|3 target controls covered
22%
SANS Incident Handler's Handbook and PICERL Methodology
5 source controls mapped|5 target controls covered
22%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
5 source controls mapped|6 target controls covered
22%
Botswana Data Protection Act (2024)
5 source controls mapped|7 target controls covered
22%
ASEAN Data Management Framework
5 source controls mapped|9 target controls covered
22%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
5 source controls mapped|5 target controls covered
22%
Laos Law on Prevention and Combating Cybercrime (2015)
5 source controls mapped|7 target controls covered
22%
French Sapin II Law (Law No. 2016-1691)
5 source controls mapped|4 target controls covered
22%
EU Taxonomy Regulation (Regulation 2020/852)
5 source controls mapped|9 target controls covered
22%
ISO/IEC 38500:2024 — Governance of IT
5 source controls mapped|5 target controls covered
22%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|5 target controls covered
22%
EU Taxonomy Regulation
5 source controls mapped|7 target controls covered
22%
ISO 37000:2021 — Governance of Organizations
5 source controls mapped|6 target controls covered
22%
ISO 20400:2017 — Sustainable Procurement
5 source controls mapped|6 target controls covered
22%
APRA CPS 230 Operational Risk Management
4 source controls mapped|9 target controls covered
17%
ISO/IEC 27010:2015
4 source controls mapped|5 target controls covered
17%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|5 target controls covered
17%
ISO 56002
4 source controls mapped|7 target controls covered
17%
ISO 37002:2021 — Whistleblowing Management Systems
4 source controls mapped|6 target controls covered
17%
Customs-Trade Partnership Against Terrorism (C-TPAT)
4 source controls mapped|9 target controls covered
17%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
4 source controls mapped|9 target controls covered
17%
EDM Council CDMC — Cloud Data Management Capabilities Framework
4 source controls mapped|4 target controls covered
17%
NIST SP 800-171A — Assessing CUI Security Requirements
4 source controls mapped|10 target controls covered
17%
C-TPAT — Customs-Trade Partnership Against Terrorism
4 source controls mapped|8 target controls covered
17%
ICAO Annex 17 — Aviation Security (AVSEC)
4 source controls mapped|4 target controls covered
17%
HIPAA Security Rule
4 source controls mapped|8 target controls covered
17%
Australia My Health Records Act 2012
4 source controls mapped|5 target controls covered
17%
DISA Security Technical Implementation Guides (STIGs)
4 source controls mapped|10 target controls covered
17%
TSA Pipeline Cybersecurity Directives
4 source controls mapped|4 target controls covered
17%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
4 source controls mapped|6 target controls covered
17%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|2 target controls covered
17%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|5 target controls covered
17%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
4 source controls mapped|5 target controls covered
17%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
4 source controls mapped|3 target controls covered
17%
EU Data Act
4 source controls mapped|2 target controls covered
17%
ISO/IEC 27400:2022
4 source controls mapped|5 target controls covered
17%
APRA Prudential Standard CPS 234 — Information Security (Australia)
4 source controls mapped|4 target controls covered
17%
China Cybersecurity Law (CSL)
4 source controls mapped|4 target controls covered
17%
Cyber Security Act 2024 (Australia)
4 source controls mapped|4 target controls covered
17%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
4 source controls mapped|4 target controls covered
17%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
4 source controls mapped|4 target controls covered
17%
Serbia Law on Personal Data Protection (2018)
4 source controls mapped|6 target controls covered
17%
ISO/IEC 30111:2019
4 source controls mapped|4 target controls covered
17%
Pakistan Personal Data Protection Bill 2023
4 source controls mapped|5 target controls covered
17%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
4 source controls mapped|4 target controls covered
17%
UK Open Banking Standard
4 source controls mapped|2 target controls covered
17%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
4 source controls mapped|5 target controls covered
17%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
4 source controls mapped|5 target controls covered
17%
Nigeria Data Protection Act 2023 (NDPA)
4 source controls mapped|3 target controls covered
17%
NERC CIP
4 source controls mapped|8 target controls covered
17%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
4 source controls mapped|4 target controls covered
17%
Philippines Cybercrime Prevention Act (RA 10175)
4 source controls mapped|3 target controls covered
17%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
4 source controls mapped|6 target controls covered
17%
Tanzania Personal Data Protection Act (Draft)
4 source controls mapped|4 target controls covered
17%
Cayman Islands Data Protection Act 2017 (DPA)
4 source controls mapped|4 target controls covered
17%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
4 source controls mapped|7 target controls covered
17%
Brunei Personal Data Protection Order 2024 (PDPO)
4 source controls mapped|6 target controls covered
17%
Zimbabwe Data Protection Act (2021)
4 source controls mapped|5 target controls covered
17%
Digital Economy Partnership Agreement (DEPA)
4 source controls mapped|4 target controls covered
17%
NIST SP 800-124 Rev 2 — Mobile Device Security
4 source controls mapped|4 target controls covered
17%
Ghana Data Protection Act 2012 (Act 843)
4 source controls mapped|3 target controls covered
17%
South Korea Personal Information Protection Act (PIPA)
4 source controls mapped|8 target controls covered
17%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
4 source controls mapped|7 target controls covered
17%
Montenegro Law on Personal Data Protection (2023)
4 source controls mapped|7 target controls covered
17%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
4 source controls mapped|8 target controls covered
17%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
4 source controls mapped|6 target controls covered
17%
EU Product Liability Directive (Directive (EU) 2024/2853)
4 source controls mapped|7 target controls covered
17%
EU Platform Work Directive (Directive 2024/2831)
4 source controls mapped|7 target controls covered
17%
EU Pay Transparency Directive (Directive 2023/970)
4 source controls mapped|7 target controls covered
17%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
4 source controls mapped|7 target controls covered
17%
China Personal Information Protection Law (PIPL)
4 source controls mapped|4 target controls covered
17%
EU Seveso III Directive (Directive 2012/18/EU)
4 source controls mapped|6 target controls covered
17%
EU European Media Freedom Act (EMFA)
4 source controls mapped|6 target controls covered
17%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
4 source controls mapped|5 target controls covered
17%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
4 source controls mapped|7 target controls covered
17%
EU Carbon Border Adjustment Mechanism (CBAM)
4 source controls mapped|5 target controls covered
17%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
4 source controls mapped|5 target controls covered
17%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
4 source controls mapped|4 target controls covered
17%
ILO Nursing Personnel Convention C149 (1977)
4 source controls mapped|5 target controls covered
17%
EU ePrivacy Directive (2002/58/EC)
4 source controls mapped|5 target controls covered
17%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
4 source controls mapped|4 target controls covered
17%
African Union Malabo Convention
4 source controls mapped|5 target controls covered
17%
Georgia Law on Personal Data Protection (2012)
4 source controls mapped|6 target controls covered
17%
Costa Rica Personal Data Protection Law (Law No. 8968)
4 source controls mapped|6 target controls covered
17%
Peru Personal Data Protection Law (Law No. 29733)
4 source controls mapped|4 target controls covered
17%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
4 source controls mapped|5 target controls covered
17%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
4 source controls mapped|4 target controls covered
17%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
4 source controls mapped|5 target controls covered
17%
Uzbekistan Law on Personal Data (No. ZRU-547)
4 source controls mapped|5 target controls covered
17%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
4 source controls mapped|6 target controls covered
17%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
4 source controls mapped|5 target controls covered
17%
Lithuania Law on Legal Protection of Personal Data (2018)
4 source controls mapped|4 target controls covered
17%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
4 source controls mapped|7 target controls covered
17%
Malta Data Protection Act (Cap. 586, 2018)
4 source controls mapped|7 target controls covered
17%
Oman Personal Data Protection Law (Royal Decree 6/2022)
4 source controls mapped|6 target controls covered
17%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
4 source controls mapped|5 target controls covered
17%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
4 source controls mapped|5 target controls covered
17%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
4 source controls mapped|6 target controls covered
17%
SQF Code Edition 9 — Safe Quality Food
4 source controls mapped|3 target controls covered
17%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
4 source controls mapped|9 target controls covered
17%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
4 source controls mapped|3 target controls covered
17%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
4 source controls mapped|5 target controls covered
17%
Connecticut Data Privacy Act (CTDPA)
4 source controls mapped|5 target controls covered
17%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|4 target controls covered
17%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|6 target controls covered
17%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|4 target controls covered
17%
ISO/IEC 29134:2023
4 source controls mapped|5 target controls covered
17%
ISO/IEC 27014:2020
4 source controls mapped|4 target controls covered
17%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
4 source controls mapped|4 target controls covered
17%
EU Markets in Crypto-Assets Regulation (MiCA)
4 source controls mapped|7 target controls covered
17%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
4 source controls mapped|4 target controls covered
17%
EU Digital Services Act — Online Gaming Platform Requirements
4 source controls mapped|3 target controls covered
17%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
4 source controls mapped|3 target controls covered
17%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
4 source controls mapped|6 target controls covered
17%
AS9100D — Aerospace Quality Management System
4 source controls mapped|8 target controls covered
17%
ISO/IEC 27003:2017
4 source controls mapped|8 target controls covered
17%
TNFD Recommendations
4 source controls mapped|7 target controls covered
17%
AASB S2 Climate-related Disclosures
4 source controls mapped|10 target controls covered
17%
3GPP Security Architecture (TS 33.501 — 5G Security)
4 source controls mapped|9 target controls covered
17%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|8 target controls covered
17%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|4 target controls covered
17%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|10 target controls covered
17%
ICH Q10 — Pharmaceutical Quality System
4 source controls mapped|6 target controls covered
17%
US OFAC Sanctions Compliance Framework
4 source controls mapped|4 target controls covered
17%
EN 50126/50128/50129 — Railway RAMS and Safety
4 source controls mapped|5 target controls covered
17%
EU PSD3 and Payment Services Regulation (Proposed)
4 source controls mapped|4 target controls covered
17%
ISO 26262:2018 — Functional Safety for Road Vehicles
4 source controls mapped|4 target controls covered
17%
EDM Council DCAM — Data Management Capability Assessment Model
4 source controls mapped|5 target controls covered
17%
ISO 8000 — Data Quality
4 source controls mapped|5 target controls covered
17%
COSO Enterprise Risk Management (ERM) Framework (2017)
4 source controls mapped|5 target controls covered
17%
SASB Standards (ISSB Integrated)
4 source controls mapped|7 target controls covered
17%
SASB Standards
4 source controls mapped|6 target controls covered
17%
ISO/IEC 25012:2008 — Data Quality Model
4 source controls mapped|3 target controls covered
17%
ISO/IEC 23894:2023
4 source controls mapped|10 target controls covered
17%
IATF 16949:2016 — Quality Management System for Automotive Production
4 source controls mapped|5 target controls covered
17%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
4 source controls mapped|4 target controls covered
17%
ECB TIBER-EU Framework
4 source controls mapped|3 target controls covered
17%
FATF Recommendation 16 — Virtual Asset Travel Rule
4 source controls mapped|5 target controls covered
17%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
17%
Privacy by Design (PbD) — Seven Foundational Principles
4 source controls mapped|3 target controls covered
17%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
4 source controls mapped|5 target controls covered
17%
ASD Strategies to Mitigate Cyber Security Incidents
3 source controls mapped|6 target controls covered
13%
Nevada Gaming Control Board Cybersecurity Requirements
3 source controls mapped|7 target controls covered
13%
Lloyd's Minimum Standards — Cyber Security
3 source controls mapped|7 target controls covered
13%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
3 source controls mapped|5 target controls covered
13%
Colorado Privacy Act
3 source controls mapped|4 target controls covered
13%
Bahrain PDPL
3 source controls mapped|4 target controls covered
13%
WCO Authorised Economic Operator (AEO) Framework
3 source controls mapped|12 target controls covered
13%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|8 target controls covered
13%
EU Chips Act (Regulation (EU) 2023/1781)
3 source controls mapped|8 target controls covered
13%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
3 source controls mapped|3 target controls covered
13%
CCPA/CPRA
3 source controls mapped|4 target controls covered
13%
COPPA
3 source controls mapped|4 target controls covered
13%
Chile DPL
3 source controls mapped|4 target controls covered
13%
Connecticut DPA
3 source controls mapped|4 target controls covered
13%
Switzerland FADP
3 source controls mapped|4 target controls covered
13%
Colombia Habeas Data Law
3 source controls mapped|4 target controls covered
13%
Argentina PDPA
3 source controls mapped|4 target controls covered
13%
APPI
3 source controls mapped|4 target controls covered
13%
Privacy Act 1988 (Australia)
3 source controls mapped|4 target controls covered
13%
Philippines DPA
3 source controls mapped|4 target controls covered
13%
Vietnam PDPD
3 source controls mapped|4 target controls covered
13%
Indonesia PDP Law
3 source controls mapped|4 target controls covered
13%
PIPEDA
3 source controls mapped|4 target controls covered
13%
Oregon Consumer Privacy Act
3 source controls mapped|4 target controls covered
13%
FDA 21 CFR Part 11
3 source controls mapped|5 target controls covered
13%
HITECH Act
3 source controls mapped|2 target controls covered
13%
Qatar DPL
3 source controls mapped|4 target controls covered
13%
Uruguay DPL
3 source controls mapped|4 target controls covered
13%
Malaysia PDPA 2010
3 source controls mapped|4 target controls covered
13%
Utah Consumer Privacy Act
3 source controls mapped|4 target controls covered
13%
Minnesota Consumer Data Privacy Act
3 source controls mapped|4 target controls covered
13%
New Hampshire Privacy Act
3 source controls mapped|4 target controls covered
13%
Tennessee IPA
3 source controls mapped|4 target controls covered
13%
Ecuador LOPDP
3 source controls mapped|4 target controls covered
13%
UK Security and Emergency Measures Direction (SEMD) — Water Industry
3 source controls mapped|5 target controls covered
13%
ISO 27799
3 source controls mapped|5 target controls covered
13%
ISO 27701
3 source controls mapped|4 target controls covered
13%
Iowa Consumer Data Protection Act
3 source controls mapped|4 target controls covered
13%
Rwanda DPL
3 source controls mapped|4 target controls covered
13%
Peru DPL
3 source controls mapped|4 target controls covered
13%
Iceland DPA
3 source controls mapped|4 target controls covered
13%
NIST SP 800-66
3 source controls mapped|5 target controls covered
13%
Maryland Online Data Privacy Act
3 source controls mapped|4 target controls covered
13%
ITIL 4
3 source controls mapped|4 target controls covered
13%
India DPDP Act
3 source controls mapped|4 target controls covered
13%
UK Data Protection Act 2018
3 source controls mapped|4 target controls covered
13%
Kentucky Consumer Data Protection Act
3 source controls mapped|4 target controls covered
13%
LGPD
3 source controls mapped|4 target controls covered
13%
Taiwan PDPA
3 source controls mapped|4 target controls covered
13%
Mauritius DPA
3 source controls mapped|4 target controls covered
13%
New Jersey Data Privacy Act
3 source controls mapped|4 target controls covered
13%
NIST SP 800-122
3 source controls mapped|4 target controls covered
13%
Saudi Arabia PDPL
3 source controls mapped|4 target controls covered
13%
PDPA Singapore
3 source controls mapped|4 target controls covered
13%
ISO 13485
3 source controls mapped|5 target controls covered
13%
Norway PDPA
3 source controls mapped|4 target controls covered
13%
Mexico LFPDPPP
3 source controls mapped|4 target controls covered
13%
Jamaica DPA
3 source controls mapped|4 target controls covered
13%
Montana Consumer Data Privacy Act
3 source controls mapped|4 target controls covered
13%
Indiana Consumer Data Protection Act
3 source controls mapped|4 target controls covered
13%
ISO 20000-1
3 source controls mapped|4 target controls covered
13%
Turkey KVKK
3 source controls mapped|4 target controls covered
13%
Defence Industry Security Program (DISP)
3 source controls mapped|4 target controls covered
13%
MDS2 (Medical Device)
3 source controls mapped|5 target controls covered
13%
Delaware Personal Data Privacy Act
3 source controls mapped|4 target controls covered
13%
MARS-E
3 source controls mapped|5 target controls covered
13%
PDPA Thailand
3 source controls mapped|4 target controls covered
13%
Dominican Republic DPL
3 source controls mapped|4 target controls covered
13%
Virginia CDPA
3 source controls mapped|4 target controls covered
13%
Texas Data Privacy Act
3 source controls mapped|4 target controls covered
13%
Liechtenstein DPA
3 source controls mapped|4 target controls covered
13%
Nebraska Data Privacy Act
3 source controls mapped|4 target controls covered
13%
China PIPL
3 source controls mapped|4 target controls covered
13%
Kenya DPA
3 source controls mapped|4 target controls covered
13%
FERPA
3 source controls mapped|4 target controls covered
13%
Nigeria NDPR
3 source controls mapped|4 target controls covered
13%
POPIA
3 source controls mapped|4 target controls covered
13%
UAE PDPL
3 source controls mapped|4 target controls covered
13%
New Zealand Privacy Act
3 source controls mapped|4 target controls covered
13%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|8 target controls covered
13%
US Executive Order 14028 — Improving the Nation's Cybersecurity
3 source controls mapped|4 target controls covered
13%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
3 source controls mapped|4 target controls covered
13%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|4 target controls covered
13%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|4 target controls covered
13%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
3 source controls mapped|5 target controls covered
13%
Portugal Law No. 58/2019 — Data Protection Implementation Act
3 source controls mapped|7 target controls covered
13%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|5 target controls covered
13%
Uruguay Personal Data Protection Act (Law No. 18.331)
3 source controls mapped|5 target controls covered
13%
EU Machinery Regulation (Regulation (EU) 2023/1230)
3 source controls mapped|5 target controls covered
13%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
3 source controls mapped|6 target controls covered
13%
Morocco Data Protection Law (09-08)
3 source controls mapped|5 target controls covered
13%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
3 source controls mapped|4 target controls covered
13%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
3 source controls mapped|3 target controls covered
13%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|4 target controls covered
13%
EU AI Liability Directive
3 source controls mapped|4 target controls covered
13%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
3 source controls mapped|2 target controls covered
13%
EU Web Accessibility Directive (Directive 2016/2102)
3 source controls mapped|3 target controls covered
13%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
3 source controls mapped|3 target controls covered
13%
IFRS 17 — Insurance Contracts
3 source controls mapped|2 target controls covered
13%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|3 target controls covered
13%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
3 source controls mapped|2 target controls covered
13%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|3 target controls covered
13%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|3 target controls covered
13%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|4 target controls covered
13%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
3 source controls mapped|5 target controls covered
13%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
3 source controls mapped|6 target controls covered
13%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
3 source controls mapped|5 target controls covered
13%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|5 target controls covered
13%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|4 target controls covered
13%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
3 source controls mapped|3 target controls covered
13%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
3 source controls mapped|2 target controls covered
13%
Fiji Data Protection Bill (2020)
3 source controls mapped|5 target controls covered
13%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|4 target controls covered
13%
EU Clinical Trials Regulation (CTR 536/2014)
3 source controls mapped|1 target controls covered
13%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|3 target controls covered
13%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|3 target controls covered
13%
Angola Personal Data Protection Law (Law No. 22/11)
3 source controls mapped|4 target controls covered
13%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
3 source controls mapped|1 target controls covered
13%
21 CFR Part 58 — Good Laboratory Practice (GLP)
3 source controls mapped|2 target controls covered
13%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|4 target controls covered
13%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|5 target controls covered
13%
Armenia Law on Protection of Personal Data (2015)
3 source controls mapped|3 target controls covered
13%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
3 source controls mapped|3 target controls covered
13%
ISO/IEC 27004:2016
3 source controls mapped|3 target controls covered
13%
21 CFR Part 211 — Current Good Manufacturing Practice
3 source controls mapped|2 target controls covered
13%
MiFID II / MiFIR
3 source controls mapped|2 target controls covered
13%
Australia NHMRC National Statement on Ethical Conduct in Human Research
3 source controls mapped|2 target controls covered
13%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
13%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
3 source controls mapped|2 target controls covered
13%
ISO/IEC 29100:2024
3 source controls mapped|3 target controls covered
13%
South Korea Credit Information Act
3 source controls mapped|1 target controls covered
13%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
13%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
13%
3GPP 5G Security Architecture (TS 33.501)
3 source controls mapped|2 target controls covered
13%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|1 target controls covered
13%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
13%
India Account Aggregator Framework (RBI)
3 source controls mapped|1 target controls covered
13%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
13%
Science Based Targets initiative (SBTi) Corporate Standard
3 source controls mapped|2 target controls covered
13%
COBIT 2019
3 source controls mapped|1 target controls covered
13%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
3 source controls mapped|1 target controls covered
13%
RICS Professional Standards — Data and Technology in Property
3 source controls mapped|1 target controls covered
13%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
13%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
3 source controls mapped|4 target controls covered
13%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
13%
Bermuda Personal Information Protection Act 2016 (PIPA)
3 source controls mapped|2 target controls covered
13%
Wisconsin Data Privacy Act (SB 670)
3 source controls mapped|3 target controls covered
13%
Online Safety Act 2021 (Australia)
3 source controls mapped|3 target controls covered
13%
ISO/IEC 27006:2024
3 source controls mapped|4 target controls covered
13%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
3 source controls mapped|3 target controls covered
13%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
13%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
3 source controls mapped|3 target controls covered
13%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|1 target controls covered
13%
WCAG 2.2
3 source controls mapped|1 target controls covered
13%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
13%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
3 source controls mapped|5 target controls covered
13%
ECSS Software Engineering Standards (ESA)
3 source controls mapped|5 target controls covered
13%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
3 source controls mapped|1 target controls covered
13%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
3 source controls mapped|4 target controls covered
13%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
3 source controls mapped|2 target controls covered
13%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
3 source controls mapped|1 target controls covered
13%
Kenya Data Protection Act 2019
3 source controls mapped|3 target controls covered
13%
ITAR — International Traffic in Arms Regulations
3 source controls mapped|2 target controls covered
13%
UK Building Safety Act 2022
3 source controls mapped|2 target controls covered
13%
EU European Health Data Space (EHDS)
3 source controls mapped|1 target controls covered
13%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|2 target controls covered
13%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
3 source controls mapped|1 target controls covered
13%
DO-178C / ED-12C — Software Considerations in Airborne Systems
3 source controls mapped|5 target controls covered
13%
South Africa Promotion of Access to Information Act (PAIA)
3 source controls mapped|1 target controls covered
13%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
13%
Jamaica Data Protection Act 2020
3 source controls mapped|3 target controls covered
13%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|4 target controls covered
13%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
3 source controls mapped|3 target controls covered
13%
Florida Digital Bill of Rights (SB 262)
3 source controls mapped|1 target controls covered
13%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
3 source controls mapped|1 target controls covered
13%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|2 target controls covered
13%
Virginia Consumer Data Protection Act (VCDPA)
3 source controls mapped|1 target controls covered
13%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|3 target controls covered
13%
Australia Online Safety Act 2021
3 source controls mapped|4 target controls covered
13%
Mauritius Data Protection Act 2017
3 source controls mapped|2 target controls covered
13%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
3 source controls mapped|3 target controls covered
13%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|1 target controls covered
13%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|1 target controls covered
13%
CDP (formerly Carbon Disclosure Project)
3 source controls mapped|9 target controls covered
13%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
3 source controls mapped|3 target controls covered
13%
ISO 22318
2 source controls mapped|3 target controls covered
9%
ISO 22316
2 source controls mapped|3 target controls covered
9%
FIRST CSIRT Services Framework and Standards
2 source controls mapped|3 target controls covered
9%
ISO 22301
2 source controls mapped|4 target controls covered
9%
ISO 22317
2 source controls mapped|3 target controls covered
9%
OWASP API Security Top 10:2023
2 source controls mapped|2 target controls covered
9%
US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements
2 source controls mapped|4 target controls covered
9%
US Consumer Product Safety Commission (CPSC) — Connected Product Safety
2 source controls mapped|2 target controls covered
9%
PropTech Security Standards — Smart Building Cybersecurity
2 source controls mapped|3 target controls covered
9%
NIST Privacy Framework Version 1.0
2 source controls mapped|4 target controls covered
9%
ASEAN Guide on AI Governance and Ethics
2 source controls mapped|2 target controls covered
9%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|3 target controls covered
9%
EASA Part-IS — Information Security in Aviation
2 source controls mapped|8 target controls covered
9%
China Data Security Law (DSL)
2 source controls mapped|4 target controls covered
9%
UK Modern Slavery Act 2015
2 source controls mapped|2 target controls covered
9%
Zambia Data Protection Act (2021)
2 source controls mapped|3 target controls covered
9%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|4 target controls covered
9%
India CERT-In Cyber Security Directions 2022
2 source controls mapped|2 target controls covered
9%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
2 source controls mapped|2 target controls covered
9%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
2 source controls mapped|4 target controls covered
9%
CISA Secure by Design Principles
2 source controls mapped|2 target controls covered
9%
Canada Artificial Intelligence and Data Act (AIDA)
2 source controls mapped|3 target controls covered
9%
Sigstore — Software Artifact Signing and Verification
2 source controls mapped|2 target controls covered
9%
ICH E6(R3) — Good Clinical Practice
2 source controls mapped|2 target controls covered
9%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
2 source controls mapped|7 target controls covered
9%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
2 source controls mapped|2 target controls covered
9%
Authorised Economic Operator (AEO) Programmes — Global Standards
2 source controls mapped|5 target controls covered
9%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
2 source controls mapped|6 target controls covered
9%
UNESCO Recommendation on the Ethics of AI
2 source controls mapped|5 target controls covered
9%
Solvency II
2 source controls mapped|4 target controls covered
9%
Responsible Minerals Initiative (RMI) — Responsible Minerals Assurance Process
2 source controls mapped|6 target controls covered
9%
ICMM Mining Principles (2024 Update)
2 source controls mapped|2 target controls covered
9%
German Supply Chain Due Diligence Act (LkSG)
2 source controls mapped|6 target controls covered
9%
OECD AI Principles (2024 Update)
2 source controls mapped|3 target controls covered
9%
UK FCA/PRA Operational Resilience Framework
2 source controls mapped|2 target controls covered
9%
CDP Corporate Questionnaire
2 source controls mapped|3 target controls covered
9%
ISO 26000:2010
2 source controls mapped|3 target controls covered
9%
ASD Essential Eight Maturity Model
1 source controls mapped|2 target controls covered
4%
ITU-T X.805 — Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
4%
Philippines Data Privacy Act (RA 10173)
1 source controls mapped|1 target controls covered
4%
Canada's Anti-Spam Legislation (CASL)
1 source controls mapped|1 target controls covered
4%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
4%
EU Better Internet for Kids (BIK+) Strategy
1 source controls mapped|1 target controls covered
4%
ISO 55001
1 source controls mapped|1 target controls covered
4%
ISO 9001
1 source controls mapped|1 target controls covered
4%
ISO 30401
1 source controls mapped|1 target controls covered
4%
ISO 37001
1 source controls mapped|1 target controls covered
4%
ISO 37301
1 source controls mapped|1 target controls covered
4%
ISO 19011
1 source controls mapped|1 target controls covered
4%
GHG Protocol
1 source controls mapped|1 target controls covered
4%
FATF 40 Recommendations
1 source controls mapped|1 target controls covered
4%
Brazil AI Framework
1 source controls mapped|3 target controls covered
4%
China AI Regulations
1 source controls mapped|4 target controls covered
4%
COSO ERM
1 source controls mapped|6 target controls covered
4%
Singapore Model AI Governance Framework (2nd Edition)
1 source controls mapped|1 target controls covered
4%
Australia AI Ethics Framework
1 source controls mapped|4 target controls covered
4%
Colorado AI Act (SB 24-205)
1 source controls mapped|2 target controls covered
4%
Colorado Privacy Act (CPA)
1 source controls mapped|1 target controls covered
4%
AML/CTF Act 2006 (Australia)
1 source controls mapped|2 target controls covered
4%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|3 target controls covered
4%
APRA CPS 220 Risk Management
1 source controls mapped|4 target controls covered
4%
Global Cross-Border Privacy Rules (Global CBPR) Forum
1 source controls mapped|1 target controls covered
4%
Aged Care Quality Standards (Australia)
1 source controls mapped|1 target controls covered
4%
Japan AI Guidelines
1 source controls mapped|4 target controls covered
4%
IEEE 7000
1 source controls mapped|3 target controls covered
4%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
1 source controls mapped|5 target controls covered
4%
NIST SP 800-37
1 source controls mapped|6 target controls covered
4%
ISO 31000
1 source controls mapped|6 target controls covered
4%
ISO 22000
1 source controls mapped|1 target controls covered
4%
EU Medical Devices Regulation (MDR 2017/745)
1 source controls mapped|1 target controls covered
4%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
4%
NIST SP 800-39
1 source controls mapped|6 target controls covered
4%
ISO 45001
1 source controls mapped|1 target controls covered
4%
ISO 42001
1 source controls mapped|3 target controls covered
4%
SEC Climate Disclosure Rule
1 source controls mapped|3 target controls covered
4%
OECD AI Principles
1 source controls mapped|4 target controls covered
4%
COSO Internal Control — Integrated Framework (2013)
1 source controls mapped|3 target controls covered
4%
EU AI Act
1 source controls mapped|3 target controls covered
4%
NIST SP 800-30
1 source controls mapped|6 target controls covered
4%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
1 source controls mapped|1 target controls covered
4%
Singapore AI Governance Framework
1 source controls mapped|4 target controls covered
4%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|4 target controls covered
4%
UK Online Safety Act 2023
1 source controls mapped|3 target controls covered
4%
EU Digital Services Act
1 source controls mapped|2 target controls covered
4%
FSSC 22000 — Food Safety System Certification
1 source controls mapped|2 target controls covered
4%
ISO 27005
1 source controls mapped|6 target controls covered
4%
Australia IRAP — Information Security Registered Assessors Program
1 source controls mapped|1 target controls covered
4%
UK Age Appropriate Design Code (Children's Code)
1 source controls mapped|1 target controls covered
4%
UNICEF Policy Guidance on AI for Children (2021)
1 source controls mapped|1 target controls covered
4%
SEC Cybersecurity Disclosure Rules
1 source controls mapped|2 target controls covered
4%
UK AI Regulation Framework
1 source controls mapped|3 target controls covered
4%
GDPR
1 source controls mapped|1 target controls covered
4%
Equator Principles (EP4, 2020)
1 source controls mapped|1 target controls covered
4%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
4%
SA8000:2014 — Social Accountability Standard
1 source controls mapped|1 target controls covered
4%
GS1 Global Standards — Supply Chain Traceability and Data Security
1 source controls mapped|3 target controls covered
4%
Space ISAC (Information Sharing and Analysis Center) — Threat Framework
1 source controls mapped|1 target controls covered
4%
ISSB Standards
1 source controls mapped|3 target controls covered
4%
EU SFDR (Sustainable Finance Disclosure Regulation)
1 source controls mapped|3 target controls covered
4%
CSRD
1 source controls mapped|3 target controls covered
4%
ISO 14001
1 source controls mapped|3 target controls covered
4%
GRI Standards
1 source controls mapped|3 target controls covered
4%
TCFD Recommendations
1 source controls mapped|3 target controls covered
4%
LEED v4.1 — Green Building Rating System (US Green Building Council)
1 source controls mapped|1 target controls covered
4%
Compare EU GMP Annex 11 — Computerised Systems with AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)

Frequently Asked Questions

What is EU GMP Annex 11 — Computerised Systems?

EU GMP Annex 11 — Computerised Systems is a compliance framework from European Union (EMA/EC) with 6 domains and 23 controls. EU GMP Annex 11 (revised 2011) provides guidance on the application of Good Manufacturing Practice (GMP) to computerised systems used in pharmaceutical manufacturing and quality control. Published by the European Commission as part of EudraLex Volume 4. Covers the complete lifecycle of computerised systems from specification through decommissioning. Key topics include risk management, validation, data integrity, electronic signatures, batch release, and cloud computing. Applicable to all computerised systems used in GMP-regulated activities. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

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

EU GMP Annex 11 — Computerised Systems has 23 controls organised across 6 domains. The largest domains are General Requirements (9 controls), Operational Phase — Data Management (5 controls), Operational Phase — Release and Continuity (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

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

EU GMP Annex 11 — Computerised Systems maps to 631 other compliance frameworks. The top mapping partners are AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) (35% coverage), CFTC System Safeguards (17 CFR 37, 38, 39, 49) (35% coverage), ASIC Cyber Resilience Good Practices (35% coverage). Use our comparison tool to explore control-level mappings between frameworks.

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

Start your EU GMP Annex 11 — 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 EU GMP Annex 11 — 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 23 controls and track your progress.

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