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FDA 21 CFR Part 11
United States
v2023
12 domains
57 controls
Electronic Records; Electronic Signatures (pharmaceutical/medical devices)
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 (12)
Audit Trail
1 controls
| Code | Title |
|---|---|
| §11.10(e) | Secure, computer-generated, time-stamped audit trails |
Closed System
6 controls
| Code | Title |
|---|---|
| §11.10(b) | Generation of accurate and complete copies |
| §11.10(c) | Record protection and retrieval |
| §11.10(d) | Limiting system access to authorized individuals |
| §11.10(f) | Operational system checks |
| §11.10(g) | Authority checks |
| §11.10(h) | Device checks |
Documentation
4 controls
| Code | Title |
|---|---|
| §11.10(i) | Personnel qualifications and training |
| §11.10(j) | Written policies holding individuals accountable |
| §11.10(k)(1) | Distribution and access control of system documentation |
| §11.10(k)(2) | Revision and change control of system documentation |
Electronic Signature
16 controls
| Code | Title |
|---|---|
| §11.100(a) | Uniqueness of electronic signatures |
| §11.100(b) | Identity verification before assigning signature |
| §11.100(c) | FDA certification of electronic signatures |
| §11.200(a)(1)(i) | Non-biometric signatures require two distinct components |
| §11.200(a)(1)(ii) | Continuous session signings |
| §11.200(a)(2) | Non-continuous signings require all components |
| §11.200(a)(3) | Signatures only usable by genuine owners |
| §11.200(b) | Biometric signature controls |
| §11.300(a) | Uniqueness of ID code and password combinations |
| §11.300(b) | Periodic checking, recalling, or revising of ID codes and passwords |
| §11.300(c) | Loss management for tokens, cards, and devices |
| §11.300(d) | Transaction safeguards against unauthorized use and detection of attempts |
| §11.300(e) | Initial and periodic testing of devices |
| §11.50(a) | Signature manifestation content |
| §11.50(b) | Signature manifestation in human-readable form |
| §11.70 | Signature/record linking |
FDA 21 CFR Part 11: Administrative Safeguards
6 controls
Organizational security management (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-06 | Security management process and risk analysis |
| FDA-CFR11-07 | Workforce security and clearance procedures |
| FDA-CFR11-08 | Information access management |
| FDA-CFR11-09 | Security awareness and training program |
| FDA-CFR11-10 | Contingency planning for ePHI |
| FDA-CFR11-11 | Business associate management |
FDA 21 CFR Part 11: Organizational Requirements
4 controls
Policies, procedures, and documentation (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-21 | Security and privacy policies |
| FDA-CFR11-22 | Documentation and record retention |
| FDA-CFR11-23 | Compliance evaluation and review |
| FDA-CFR11-24 | Incident reporting procedures |
FDA 21 CFR Part 11: Patient Data Protection
5 controls
Safeguarding protected health information (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-01 | ePHI access controls and authorization |
| FDA-CFR11-02 | ePHI encryption at rest and in transit |
| FDA-CFR11-03 | Minimum necessary standard enforcement |
| FDA-CFR11-04 | Patient data de-identification procedures |
| FDA-CFR11-05 | Audit trail for ePHI access |
FDA 21 CFR Part 11: Physical Safeguards
4 controls
Physical security for systems with ePHI (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-17 | Facility access controls |
| FDA-CFR11-18 | Workstation security and use policies |
| FDA-CFR11-19 | Device and media controls |
| FDA-CFR11-20 | Disposal and re-use procedures |
FDA 21 CFR Part 11: Technical Safeguards
5 controls
Technical measures for ePHI protection (FDA 21 CFR Part 11)
| Code | Title |
|---|---|
| FDA-CFR11-12 | Unique user identification and authentication |
| FDA-CFR11-13 | Automatic logoff and session management |
| FDA-CFR11-14 | Audit controls and monitoring |
| FDA-CFR11-15 | Integrity controls for ePHI |
| FDA-CFR11-16 | Transmission security and encryption |
Open System
1 controls
| Code | Title |
|---|---|
| §11.30 | Controls for open systems |
Other
4 controls
| Code | Title |
|---|---|
| §11.1(a) | Scope of Part 11 |
| §11.2(a) | Implementation for paper-equivalent records |
| §11.2(b) | Electronic submissions to FDA |
| §11.3(b) | Definitions of key terms |
Validation
1 controls
| Code | Title |
|---|---|
| §11.10(a) | Validation of closed systems |
Your Compliance Coverage
If you comply with FDA 21 CFR Part 11, you already cover:
NIS2 Directive Implementing Acts
19%
11 controls mapped
Compare →ISO 13485
19%
11 controls mapped
Compare →UK Telecommunications (Security) Act 2021
19%
11 controls mapped
Compare →+ 564 more: US Gramm-Leach-Bliley Act (GLBA) - Higher Education Safeguards Rule (19%), NIST SP 800-66 (19%)
See all 567 mapped frameworks ↓Maps to 567 other frameworks
57 total controls
NIS2 Directive Implementing Acts
11 source controls mapped|14 target controls covered
19%
ISO 13485
11 source controls mapped|13 target controls covered
19%
UK Telecommunications (Security) Act 2021
11 source controls mapped|11 target controls covered
19%
US Gramm-Leach-Bliley Act (GLBA) - Higher Education Safeguards Rule
11 source controls mapped|16 target controls covered
19%
NIST SP 800-66
11 source controls mapped|10 target controls covered
19%
TISAX - Trusted Information Security Assessment Exchange
11 source controls mapped|15 target controls covered
19%
ISO 27799
11 source controls mapped|12 target controls covered
19%
GLI-33 - Gaming Laboratories International Event Wagering Systems
11 source controls mapped|10 target controls covered
19%
MDS2 (Medical Device)
11 source controls mapped|10 target controls covered
19%
MARS-E
11 source controls mapped|11 target controls covered
19%
Cloud Security Alliance Cloud Controls Matrix (CCM) v4.0.1
10 source controls mapped|18 target controls covered
18%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
10 source controls mapped|9 target controls covered
18%
Customs-Trade Partnership Against Terrorism (C-TPAT)
10 source controls mapped|7 target controls covered
18%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
10 source controls mapped|10 target controls covered
18%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
10 source controls mapped|8 target controls covered
18%
HIPAA Security Rule
10 source controls mapped|15 target controls covered
18%
FAA Cybersecurity Framework for Aviation
10 source controls mapped|9 target controls covered
18%
Oman National Cybersecurity Framework
10 source controls mapped|6 target controls covered
18%
FTC Safeguards Rule (16 CFR Part 314)
10 source controls mapped|11 target controls covered
18%
FTC GLBA Safeguards Rule (16 CFR Part 314)
10 source controls mapped|10 target controls covered
18%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
10 source controls mapped|8 target controls covered
18%
Canada ITSG-33 - IT Security Risk Management
10 source controls mapped|8 target controls covered
18%
New Zealand Information Security Manual (NZISM)
10 source controls mapped|8 target controls covered
18%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
10 source controls mapped|8 target controls covered
18%
South Korea Cloud Security Assurance Program (CSAP)
10 source controls mapped|8 target controls covered
18%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
10 source controls mapped|8 target controls covered
18%
NIST Privacy Framework 1.0
10 source controls mapped|8 target controls covered
18%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
10 source controls mapped|10 target controls covered
18%
EIOPA Guidelines on ICT Security and Governance (EIOPA‑BoS‑23/146, 2023)
10 source controls mapped|9 target controls covered
18%
Telecommunications Sector Security Reforms (TSSR)
10 source controls mapped|9 target controls covered
18%
Defence Security Principles Framework (DSPF)
10 source controls mapped|22 target controls covered
18%
Protective Security Policy Framework (PSPF) Release 2024
10 source controls mapped|22 target controls covered
18%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
9 source controls mapped|8 target controls covered
16%
FBI CJIS Security Policy
9 source controls mapped|12 target controls covered
16%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
9 source controls mapped|15 target controls covered
16%
CSA STAR (Security, Trust, Assurance, and Risk)
9 source controls mapped|6 target controls covered
16%
ASD Information Security Manual (ISM)
9 source controls mapped|25 target controls covered
16%
NIST SP 800-82 Rev 3 - Guide to OT Security
9 source controls mapped|6 target controls covered
16%
NIST SP 800-53 Rev 5
9 source controls mapped|20 target controls covered
16%
ISO 27001:2022
9 source controls mapped|10 target controls covered
16%
UK Gambling Commission - Cyber Resilience Requirements
9 source controls mapped|7 target controls covered
16%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
9 source controls mapped|7 target controls covered
16%
C-TPAT - Customs-Trade Partnership Against Terrorism
9 source controls mapped|13 target controls covered
16%
Spain ENS
8 source controls mapped|10 target controls covered
14%
DoD Zero Trust Reference Architecture
8 source controls mapped|11 target controls covered
14%
CISA Industrial Control Systems (ICS) Security Guidance
8 source controls mapped|10 target controls covered
14%
FedRAMP Rev 5
8 source controls mapped|18 target controls covered
14%
CIS Controls v8
8 source controls mapped|9 target controls covered
14%
ANSSI Cybersecurity Framework
8 source controls mapped|12 target controls covered
14%
BSI IT-Grundschutz
8 source controls mapped|11 target controls covered
14%
NIST SP 800-171A - Assessing CUI Security Requirements
8 source controls mapped|15 target controls covered
14%
Belgium CyberFundamentals
8 source controls mapped|11 target controls covered
14%
NAIC Insurance Data Security Model Law (MDL-668)
8 source controls mapped|10 target controls covered
14%
CISA Zero Trust Maturity Model
8 source controls mapped|11 target controls covered
14%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
8 source controls mapped|6 target controls covered
14%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
8 source controls mapped|3 target controls covered
14%
Cyber Essentials Plus
8 source controls mapped|10 target controls covered
14%
PCI DSS v4.0
8 source controls mapped|13 target controls covered
14%
NIST Privacy Framework Version 1.0
8 source controls mapped|4 target controls covered
14%
Saudi NCA ECC
8 source controls mapped|11 target controls covered
14%
DISA Security Technical Implementation Guides (STIGs)
8 source controls mapped|12 target controls covered
14%
FISMA
8 source controls mapped|11 target controls covered
14%
Ghana Cybersecurity Act
8 source controls mapped|12 target controls covered
14%
NIST SP 800-171
8 source controls mapped|12 target controls covered
14%
NIST SP 800-53A
8 source controls mapped|10 target controls covered
14%
South Korea ISMS-P
8 source controls mapped|7 target controls covered
14%
NIST SP 800-172
8 source controls mapped|12 target controls covered
14%
Delaware Online Privacy and Protection Act (proposed)
8 source controls mapped|4 target controls covered
14%
Privacy Act 1988 (Australia)
8 source controls mapped|4 target controls covered
14%
India DPDP Act
8 source controls mapped|4 target controls covered
14%
Law No. 172-13 on the Protection of Personal Data
8 source controls mapped|4 target controls covered
14%
Ley Orgánica de Protección de Datos Personales (LOPDP)
8 source controls mapped|4 target controls covered
14%
Bahrain PDPL
8 source controls mapped|4 target controls covered
14%
CCPA/CPRA
8 source controls mapped|4 target controls covered
14%
Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data
8 source controls mapped|5 target controls covered
14%
Chile DPL
8 source controls mapped|4 target controls covered
14%
Colorado Privacy Act
8 source controls mapped|4 target controls covered
14%
ISO/IEC 27011:2024
8 source controls mapped|7 target controls covered
14%
CTDPA (Connecticut Data Privacy Act)
8 source controls mapped|4 target controls covered
14%
APPI
8 source controls mapped|4 target controls covered
14%
Argentina PDPA
8 source controls mapped|4 target controls covered
14%
COPPA
8 source controls mapped|4 target controls covered
14%
Switzerland FADP
8 source controls mapped|4 target controls covered
14%
NIST SP 800-122
8 source controls mapped|4 target controls covered
14%
LGPD
8 source controls mapped|5 target controls covered
14%
Minnesota Consumer Data Privacy Act
8 source controls mapped|4 target controls covered
14%
Nebraska Data Privacy Act
8 source controls mapped|4 target controls covered
14%
Mexico LFPDPPP
8 source controls mapped|4 target controls covered
14%
Rwanda DPL
8 source controls mapped|4 target controls covered
14%
FERPA
8 source controls mapped|4 target controls covered
14%
Jamaica DPA
8 source controls mapped|4 target controls covered
14%
New Hampshire Privacy Act
8 source controls mapped|4 target controls covered
14%
UK Data Protection Act 2018
8 source controls mapped|4 target controls covered
14%
PIPEDA
8 source controls mapped|4 target controls covered
14%
New Zealand Privacy Act
8 source controls mapped|4 target controls covered
14%
US ITAR and EAR - Export Control and Data Security
8 source controls mapped|7 target controls covered
14%
UAE PDPL
8 source controls mapped|4 target controls covered
14%
Saudi Arabia PDPL
8 source controls mapped|4 target controls covered
14%
Iceland DPA
8 source controls mapped|4 target controls covered
14%
Kenya DPA
8 source controls mapped|4 target controls covered
14%
Kenya Data Protection Act
8 source controls mapped|4 target controls covered
14%
POPIA
8 source controls mapped|4 target controls covered
14%
Texas Data Privacy Act
8 source controls mapped|4 target controls covered
14%
Indiana Consumer Data Protection Act
8 source controls mapped|6 target controls covered
14%
Virginia CDPA
8 source controls mapped|4 target controls covered
14%
Vietnam PDPD
8 source controls mapped|4 target controls covered
14%
Qatar DPL
8 source controls mapped|4 target controls covered
14%
Kentucky Consumer Data Protection Act
8 source controls mapped|6 target controls covered
14%
Mauritius DPA
8 source controls mapped|4 target controls covered
14%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
8 source controls mapped|5 target controls covered
14%
Norway PDPA
8 source controls mapped|4 target controls covered
14%
Peru DPL
8 source controls mapped|4 target controls covered
14%
China PIPL
8 source controls mapped|4 target controls covered
14%
New Jersey Data Privacy Act
8 source controls mapped|4 target controls covered
14%
ISO 27701
8 source controls mapped|4 target controls covered
14%
Liechtenstein DPA
8 source controls mapped|4 target controls covered
14%
Iowa Consumer Data Protection Act
8 source controls mapped|6 target controls covered
14%
Utah Consumer Privacy Act
8 source controls mapped|4 target controls covered
14%
Taiwan PDPA
8 source controls mapped|4 target controls covered
14%
Uruguay DPL
8 source controls mapped|4 target controls covered
14%
Oregon Consumer Privacy Act
8 source controls mapped|4 target controls covered
14%
Turkey KVKK
8 source controls mapped|4 target controls covered
14%
Montana Consumer Data Privacy Act
8 source controls mapped|4 target controls covered
14%
Indonesia PDP Law
8 source controls mapped|4 target controls covered
14%
Maryland Online Data Privacy Act
8 source controls mapped|4 target controls covered
14%
Nigeria NDPR
8 source controls mapped|4 target controls covered
14%
PDPA Thailand
8 source controls mapped|4 target controls covered
14%
Tennessee IPA
8 source controls mapped|4 target controls covered
14%
Philippines DPA
8 source controls mapped|4 target controls covered
14%
PDPA Singapore
8 source controls mapped|4 target controls covered
14%
Malaysia PDPA 2010
8 source controls mapped|4 target controls covered
14%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
8 source controls mapped|3 target controls covered
14%
C5 (Germany)
7 source controls mapped|7 target controls covered
12%
Proposal for a Regulation on Cyber Resilience Act (CRA)
7 source controls mapped|8 target controls covered
12%
AWS Well-Architected Security Pillar
7 source controls mapped|7 target controls covered
12%
BSIMM
7 source controls mapped|8 target controls covered
12%
ETSI EN 303 645
7 source controls mapped|10 target controls covered
12%
OWASP ASVS
7 source controls mapped|9 target controls covered
12%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
7 source controls mapped|2 target controls covered
12%
HL7 FHIR Security Framework
7 source controls mapped|11 target controls covered
12%
OWASP Top 10:2025
7 source controls mapped|8 target controls covered
12%
CAIQ (CSA)
7 source controls mapped|8 target controls covered
12%
WCO Authorised Economic Operator (AEO) Framework
7 source controls mapped|17 target controls covered
12%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
7 source controls mapped|6 target controls covered
12%
Critical Raw Materials Act (Proposed Regulation COM(2023) 192)
7 source controls mapped|6 target controls covered
12%
EU Chips Act (Regulation (EU) 2023/1781)
7 source controls mapped|6 target controls covered
12%
Azure Security Benchmark
7 source controls mapped|8 target controls covered
12%
ASD Strategies to Mitigate Cyber Security Incidents
7 source controls mapped|6 target controls covered
12%
MITRE D3FEND
7 source controls mapped|9 target controls covered
12%
3GPP Security
7 source controls mapped|9 target controls covered
12%
California IoT Security Law
7 source controls mapped|8 target controls covered
12%
Regulation (EU) 2019/1239 on the Maritime Single Window (MSW)
7 source controls mapped|2 target controls covered
12%
ISMAP (Japan)
7 source controls mapped|8 target controls covered
12%
NIST SP 800-144
7 source controls mapped|8 target controls covered
12%
CCSDS 350.0-G-3 - Space Communications Security (Consultative Committee for Space Data Systems)
7 source controls mapped|8 target controls covered
12%
NIST SP 800-181
7 source controls mapped|9 target controls covered
12%
UNECE WP.29 R156
7 source controls mapped|9 target controls covered
12%
ISO 27017
7 source controls mapped|7 target controls covered
12%
NIST SP 800-115
7 source controls mapped|9 target controls covered
12%
ISO/SAE 21434
7 source controls mapped|9 target controls covered
12%
NIST SP 800-128
7 source controls mapped|9 target controls covered
12%
NIST SP 800-183
7 source controls mapped|8 target controls covered
12%
PTES
7 source controls mapped|9 target controls covered
12%
NIST SP 800-145
7 source controls mapped|7 target controls covered
12%
NIST SP 800-88
7 source controls mapped|9 target controls covered
12%
NIST SP 800-61
7 source controls mapped|8 target controls covered
12%
NIST SP 800-187
7 source controls mapped|10 target controls covered
12%
UNECE WP.29 R155
7 source controls mapped|8 target controls covered
12%
NIST SP 800-207
7 source controls mapped|8 target controls covered
12%
OWASP SAMM
7 source controls mapped|7 target controls covered
12%
PropTech Security Standards - Smart Building Cybersecurity
7 source controls mapped|5 target controls covered
12%
ISO 27043
7 source controls mapped|9 target controls covered
12%
ISO 27018
7 source controls mapped|8 target controls covered
12%
OWASP MASVS
7 source controls mapped|7 target controls covered
12%
SSDF (NIST)
7 source controls mapped|9 target controls covered
12%
O-RAN Alliance Security Specifications (O-RAN.WG11)
7 source controls mapped|4 target controls covered
12%
NIST SP 800-146
7 source controls mapped|7 target controls covered
12%
NIST SP 800-218
7 source controls mapped|8 target controls covered
12%
SLSA
7 source controls mapped|8 target controls covered
12%
NIST SP 800-63
7 source controls mapped|7 target controls covered
12%
NIST SP 800-160
7 source controls mapped|9 target controls covered
12%
ISO 27002:2022
7 source controls mapped|9 target controls covered
12%
MTCS (Singapore)
7 source controls mapped|7 target controls covered
12%
NIST SP 800-123
7 source controls mapped|8 target controls covered
12%
NIST SP 800-92
7 source controls mapped|8 target controls covered
12%
NIST SP 800-161
7 source controls mapped|8 target controls covered
12%
UK PSTI Act
7 source controls mapped|9 target controls covered
12%
OpenSSF Scorecard
7 source controls mapped|11 target controls covered
12%
NIST SP 800-190
7 source controls mapped|7 target controls covered
12%
NIST SP 800-150
7 source controls mapped|8 target controls covered
12%
NIST SP 800-137
7 source controls mapped|10 target controls covered
12%
SIG (Shared Assessments)
7 source controls mapped|8 target controls covered
12%
Sigstore - Software Artifact Signing and Verification
7 source controls mapped|7 target controls covered
12%
MITRE ATT&CK
7 source controls mapped|9 target controls covered
12%
EDM Council CDMC - Cloud Data Management Capability Framework
7 source controls mapped|4 target controls covered
12%
HKMA Cyber Resilience Assessment Framework (C-RAF)
7 source controls mapped|4 target controls covered
12%
RBI Cybersecurity Framework for Banks
7 source controls mapped|4 target controls covered
12%
Turkey Personal Data Protection Law (KVKK - Law No. 6698)
7 source controls mapped|3 target controls covered
12%
Philippines Data Privacy Act (RA 10173)
7 source controls mapped|5 target controls covered
12%
NIS2 Directive
7 source controls mapped|9 target controls covered
12%
South Korea PIPA
7 source controls mapped|3 target controls covered
12%
Bermuda Personal Information Protection Act 2016 (PIPA)
7 source controls mapped|3 target controls covered
12%
OWASP API Security Top 10:2023
6 source controls mapped|5 target controls covered
11%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)
6 source controls mapped|4 target controls covered
11%
OWASP DevSecOps Maturity Model (DSOMM)
6 source controls mapped|6 target controls covered
11%
Chile Personal Data Protection Law (Law No. 21.719)
6 source controls mapped|4 target controls covered
11%
Australian Energy Sector Cyber Security Framework (AESCSF)
6 source controls mapped|7 target controls covered
11%
DFARS 252.204-7012 - Safeguarding Covered Defense Information
6 source controls mapped|4 target controls covered
11%
Connecticut Data Privacy Act (CTDPA)
6 source controls mapped|11 target controls covered
11%
ISO/IEC 27400:2022
6 source controls mapped|4 target controls covered
11%
Secure by Design: A Guide for Manufacturers (CISA)
6 source controls mapped|5 target controls covered
11%
CNCF Security Technical Advisory Group (TAG)
6 source controls mapped|4 target controls covered
11%
IRS Publication 1075 - Tax Information Security Guidelines
6 source controls mapped|2 target controls covered
11%
TSA Pipeline Cybersecurity Directives
6 source controls mapped|4 target controls covered
11%
IEC 62351 - Power Systems Communication Security
6 source controls mapped|3 target controls covered
11%
ISO/IEC 27010:2015
6 source controls mapped|4 target controls covered
11%
Australian Information Security Manual
6 source controls mapped|4 target controls covered
11%
HITECH Act
6 source controls mapped|2 target controls covered
11%
BSI C5 - Cloud Computing Compliance Criteria Catalogue
6 source controls mapped|3 target controls covered
11%
Australia My Health Records Act 2012
6 source controls mapped|2 target controls covered
11%
Colorado Privacy Act (CPA)
5 source controls mapped|11 target controls covered
9%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
5 source controls mapped|6 target controls covered
9%
ASIC Cyber Resilience Good Practices
5 source controls mapped|2 target controls covered
9%
TSA Pipeline Security
5 source controls mapped|5 target controls covered
9%
SWIFT Customer Security Programme (CSP)
5 source controls mapped|4 target controls covered
9%
IATA Operational Safety Audit (IOSA) Standards Manual
5 source controls mapped|4 target controls covered
9%
Zimbabwe Data Protection Act (2021)
5 source controls mapped|5 target controls covered
9%
NIST SP 800-124 Rev 2 - Mobile Device Security
5 source controls mapped|4 target controls covered
9%
ISO 20000-1
5 source controls mapped|2 target controls covered
9%
DORA
5 source controls mapped|5 target controls covered
9%
SSAE 18 SOC 1 - Report on Controls at a Service Organisation (ICFR)
5 source controls mapped|3 target controls covered
9%
ILO Nursing Personnel Convention C149 (1977)
5 source controls mapped|2 target controls covered
9%
6th Anti-Money Laundering Directive (AMLD6, Directive (EU) 2018/1673) - superseded by AMLD7
5 source controls mapped|2 target controls covered
9%
ISO 8000 - Data Quality
5 source controls mapped|2 target controls covered
9%
FATF Recommendation 16 - Virtual Asset Travel Rule
5 source controls mapped|3 target controls covered
9%
Privacy by Design (PbD) - Seven Foundational Principles
5 source controls mapped|2 target controls covered
9%
BS 65000:2014 - Guidance on Organizational Resilience
5 source controls mapped|2 target controls covered
9%
NIST AI Risk Management Framework (AI RMF 1.0)
5 source controls mapped|5 target controls covered
9%
NIST AI 600-1 Generative AI Profile
5 source controls mapped|5 target controls covered
9%
Annex 11 to EU GMP - Computerised Systems
5 source controls mapped|3 target controls covered
9%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|5 target controls covered
9%
Defence Industry Security Program (DISP)
5 source controls mapped|4 target controls covered
9%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
5 source controls mapped|4 target controls covered
9%
ISO 28001:2007 Supply Chain Security Management
5 source controls mapped|3 target controls covered
9%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
5 source controls mapped|3 target controls covered
9%
Australia Consumer Data Right - Banking (CDR)
5 source controls mapped|7 target controls covered
9%
eIDAS 2.0 - EU Digital Identity Regulation
4 source controls mapped|4 target controls covered
7%
EMV 3‑D Secure (3DS) - Payment Authentication Protocol
4 source controls mapped|5 target controls covered
7%
3GPP 5G Security Architecture (TS 33.501)
4 source controls mapped|7 target controls covered
7%
3GPP Security Architecture (TS 33.501 - 5G Security)
4 source controls mapped|7 target controls covered
7%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
4 source controls mapped|5 target controls covered
7%
Armenia Law on Protection of Personal Data (2015)
4 source controls mapped|3 target controls covered
7%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|3 target controls covered
7%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|3 target controls covered
7%
TEFCA - Trusted Exchange Framework and Common Agreement
4 source controls mapped|4 target controls covered
7%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
4 source controls mapped|2 target controls covered
7%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
4 source controls mapped|2 target controls covered
7%
PCI DSS 4.0
4 source controls mapped|3 target controls covered
7%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
4 source controls mapped|1 target controls covered
7%
Russia Federal Law on Personal Data (152-FZ)
4 source controls mapped|2 target controls covered
7%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
4 source controls mapped|3 target controls covered
7%
Wisconsin Data Privacy Act (SB 670)
4 source controls mapped|4 target controls covered
7%
Tennessee Information Protection Act (TIPA)
4 source controls mapped|4 target controls covered
7%
ITU-T X.805 - Security Architecture for End-to-End Communications
4 source controls mapped|2 target controls covered
7%
Florida Digital Bill of Rights (SB 262)
4 source controls mapped|3 target controls covered
7%
US Executive Order 14028 - Improving the Nation's Cybersecurity
4 source controls mapped|2 target controls covered
7%
ESRB Privacy Certified
4 source controls mapped|4 target controls covered
7%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
4 source controls mapped|5 target controls covered
7%
EAR - Export Administration Regulations
4 source controls mapped|8 target controls covered
7%
EU Digital Markets Act
4 source controls mapped|5 target controls covered
7%
C2M2
4 source controls mapped|5 target controls covered
7%
DO-326A / ED-202A
4 source controls mapped|4 target controls covered
7%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
4 source controls mapped|4 target controls covered
7%
BIMCO Cyber Security
4 source controls mapped|4 target controls covered
7%
API 1164
4 source controls mapped|4 target controls covered
7%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|2 target controls covered
7%
ISO 27019
4 source controls mapped|4 target controls covered
7%
IEEE 1686
4 source controls mapped|4 target controls covered
7%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
4 source controls mapped|3 target controls covered
7%
NIST SP 1800-32
4 source controls mapped|4 target controls covered
7%
IEC 62443
4 source controls mapped|4 target controls covered
7%
Barbados Data Protection Act 2019
4 source controls mapped|3 target controls covered
7%
COSO Internal Control - Integrated Framework (2013)
4 source controls mapped|3 target controls covered
7%
ASEAN Data Management Framework
4 source controls mapped|5 target controls covered
7%
Voluntary Principles on Security and Human Rights (VPs)
4 source controls mapped|3 target controls covered
7%
US OFAC Sanctions Compliance Framework
4 source controls mapped|3 target controls covered
7%
Australia AI Ethics Framework
4 source controls mapped|2 target controls covered
7%
China Data Security Law (DSL)
4 source controls mapped|4 target controls covered
7%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
4 source controls mapped|3 target controls covered
7%
Laos Law on Prevention and Combating Cybercrime (2015)
4 source controls mapped|6 target controls covered
7%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (PDPL)
4 source controls mapped|3 target controls covered
7%
Saudi PDPL
4 source controls mapped|4 target controls covered
7%
Korea PIPA
4 source controls mapped|2 target controls covered
7%
Japan APPI
4 source controls mapped|2 target controls covered
7%
GDPR
4 source controls mapped|7 target controls covered
7%
Brazil AI Framework
4 source controls mapped|2 target controls covered
7%
Administrative Measures for the Security Assessment of Generative AI Services (2023) and Algorithmic Recommendation Management Provisions (2022)
4 source controls mapped|2 target controls covered
7%
EU AI Act
4 source controls mapped|5 target controls covered
7%
South Korea Personal Information Protection Act (PIPA)
4 source controls mapped|2 target controls covered
7%
ASEAN Guide on AI Governance and Ethics
4 source controls mapped|2 target controls covered
7%
China Personal Information Protection Law (PIPL)
4 source controls mapped|5 target controls covered
7%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
4 source controls mapped|3 target controls covered
7%
ISO/IEC 23894:2023
4 source controls mapped|4 target controls covered
7%
Singapore AI Governance Framework
4 source controls mapped|2 target controls covered
7%
Japan AI Guidelines
4 source controls mapped|2 target controls covered
7%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
4 source controls mapped|3 target controls covered
7%
UNICEF Policy Guidance on AI for Children (2021)
4 source controls mapped|2 target controls covered
7%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|2 target controls covered
7%
UK AI Regulation Framework
4 source controls mapped|2 target controls covered
7%
Nevada Gaming Control Board Cybersecurity Requirements
4 source controls mapped|4 target controls covered
7%
Lloyd's Minimum Standards - Cyber Security
4 source controls mapped|4 target controls covered
7%
UK Age Appropriate Design Code (Children's Code)
4 source controls mapped|2 target controls covered
7%
UNESCO Recommendation on the Ethics of AI
4 source controls mapped|3 target controls covered
7%
Zambia Data Protection Act (2021)
4 source controls mapped|4 target controls covered
7%
OECD AI Principles
4 source controls mapped|2 target controls covered
7%
IEEE 7000
4 source controls mapped|2 target controls covered
7%
Trinidad and Tobago Data Protection Act 2011
4 source controls mapped|5 target controls covered
7%
Czech Republic Act on the Protection of Personal Data (Act No. 110/2019 Coll.)
4 source controls mapped|4 target controls covered
7%
Botswana Data Protection Act (2024)
4 source controls mapped|4 target controls covered
7%
UK GDPR (UK General Data Protection Regulation)
4 source controls mapped|3 target controls covered
7%
ISO 42001
4 source controls mapped|2 target controls covered
7%
UK Modern Slavery Act 2015
4 source controls mapped|2 target controls covered
7%
Angola Personal Data Protection Law (Law No. 22/11)
4 source controls mapped|5 target controls covered
7%
MiFID II / MiFIR
4 source controls mapped|2 target controls covered
7%
EU Clinical Trials Regulation (CTR 536/2014)
4 source controls mapped|2 target controls covered
7%
Uganda Data Protection and Privacy Act (2019)
4 source controls mapped|5 target controls covered
7%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
3 source controls mapped|4 target controls covered
5%
ASD Essential Eight Maturity Model
3 source controls mapped|6 target controls covered
5%
SWIFT CSCF
3 source controls mapped|2 target controls covered
5%
ISO 19011
3 source controls mapped|4 target controls covered
5%
Digital Economy Partnership Agreement (DEPA)
3 source controls mapped|2 target controls covered
5%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
3 source controls mapped|4 target controls covered
5%
UK Open Banking Standard
3 source controls mapped|4 target controls covered
5%
FIDO2 and W3C WebAuthn Standard
3 source controls mapped|3 target controls covered
5%
NIST Cybersecurity Framework 2.0
3 source controls mapped|5 target controls covered
5%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|3 target controls covered
5%
RFC 2350 - Expectations for Computer Security Incident Response (BCP 21)
3 source controls mapped|2 target controls covered
5%
SSAE 18 - Attestation Standards (SOC Reporting)
3 source controls mapped|5 target controls covered
5%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
3 source controls mapped|2 target controls covered
5%
ISO 27005
3 source controls mapped|4 target controls covered
5%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
3 source controls mapped|3 target controls covered
5%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
3 source controls mapped|2 target controls covered
5%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|4 target controls covered
5%
EU Data Act
3 source controls mapped|1 target controls covered
5%
SOC 2
3 source controls mapped|2 target controls covered
5%
ITIL 4
3 source controls mapped|1 target controls covered
5%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|3 target controls covered
5%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|3 target controls covered
5%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|4 target controls covered
5%
Pakistan Personal Data Protection Bill 2023
3 source controls mapped|2 target controls covered
5%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
3 source controls mapped|3 target controls covered
5%
Portugal Law No. 58/2019 - Data Protection Implementation Act
3 source controls mapped|3 target controls covered
5%
Japan Act on Specified Commercial Transactions (ASCT) - Digital Services
3 source controls mapped|3 target controls covered
5%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
3 source controls mapped|1 target controls covered
5%
Greece Law 4624/2019 - Hellenic Data Protection Authority (HDPA) Implementation Act
3 source controls mapped|2 target controls covered
5%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
3 source controls mapped|2 target controls covered
5%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|5 target controls covered
5%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|2 target controls covered
5%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|3 target controls covered
5%
EU Machinery Regulation (Regulation (EU) 2023/1230)
3 source controls mapped|2 target controls covered
5%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
3 source controls mapped|1 target controls covered
5%
Morocco Data Protection Law (09-08)
3 source controls mapped|1 target controls covered
5%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
3 source controls mapped|2 target controls covered
5%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 - CMA Directive)
3 source controls mapped|2 target controls covered
5%
Digital Services Act (DSA) - Regulation (EU) 2022/2065
3 source controls mapped|3 target controls covered
5%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
3 source controls mapped|1 target controls covered
5%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|2 target controls covered
5%
Netherlands GDPR Implementation Act (UAVG - Uitvoeringswet AVG, 2018)
3 source controls mapped|1 target controls covered
5%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
3 source controls mapped|4 target controls covered
5%
EU Carbon Border Adjustment Mechanism (CBAM)
3 source controls mapped|1 target controls covered
5%
Digital Services Act (Regulation (EU) 2022/2065 of the European Parliament and of the Council of 6 July 2022)
3 source controls mapped|1 target controls covered
5%
EU European Media Freedom Act (EMFA)
3 source controls mapped|1 target controls covered
5%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|2 target controls covered
5%
African Union Malabo Convention
3 source controls mapped|1 target controls covered
5%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
3 source controls mapped|2 target controls covered
5%
Peru Personal Data Protection Law (Law No. 29733)
3 source controls mapped|1 target controls covered
5%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|5 target controls covered
5%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
3 source controls mapped|1 target controls covered
5%
Georgia Law on Personal Data Protection (2012)
3 source controls mapped|3 target controls covered
5%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
3 source controls mapped|2 target controls covered
5%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
3 source controls mapped|2 target controls covered
5%
Montenegro Law on Personal Data Protection (2023)
3 source controls mapped|5 target controls covered
5%
Uruguay Personal Data Protection Act (Law No. 18.331)
3 source controls mapped|3 target controls covered
5%
Lithuania Law on Legal Protection of Personal Data (2018)
3 source controls mapped|2 target controls covered
5%
Oman Personal Data Protection Law (Royal Decree 6/2022)
3 source controls mapped|1 target controls covered
5%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
3 source controls mapped|1 target controls covered
5%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|3 target controls covered
5%
ICH E6(R2) Good Clinical Practice - Data Integrity and Electronic Systems
3 source controls mapped|1 target controls covered
5%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
3 source controls mapped|1 target controls covered
5%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|3 target controls covered
5%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
5%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|3 target controls covered
5%
EU Data Governance Act (DGA)
3 source controls mapped|1 target controls covered
5%
EU Energy Performance of Buildings Directive (EPBD Recast) - Draft Directive (2023/0317 COD)
3 source controls mapped|1 target controls covered
5%
Law No. 2013-450 of 19 June 2013 on the Protection of Personal Data
3 source controls mapped|1 target controls covered
5%
Costa Rica Personal Data Protection Law (Law No. 8968) as amended by Executive Decree No. 42089-MGP
3 source controls mapped|1 target controls covered
5%
Uzbekistan Law on Personal Data (No. ZRU-547)
3 source controls mapped|1 target controls covered
5%
Malta Data Protection Act (Cap. 586, 2018)
3 source controls mapped|2 target controls covered
5%
Serbia Law on Personal Data Protection (2018)
3 source controls mapped|2 target controls covered
5%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
3 source controls mapped|2 target controls covered
5%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
3 source controls mapped|1 target controls covered
5%
EU Product Liability Directive (Directive (EU) 2023/2845)
3 source controls mapped|1 target controls covered
5%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
3 source controls mapped|1 target controls covered
5%
Directive (EU) 2023/970 on pay transparency
3 source controls mapped|1 target controls covered
5%
Brunei Personal Data Protection Order 2022 (PDPO)
3 source controls mapped|1 target controls covered
5%
Singapore Payment Services Act (PSA) - Digital Payment Token Regulation
3 source controls mapped|2 target controls covered
5%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|1 target controls covered
5%
Australia Online Safety Act 2021
3 source controls mapped|1 target controls covered
5%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|3 target controls covered
5%
Kenya Data Protection Act 2019
3 source controls mapped|3 target controls covered
5%
Jamaica Data Protection Act 2020
3 source controls mapped|2 target controls covered
5%
Mauritius Data Protection Act 2017
3 source controls mapped|3 target controls covered
5%
Cayman Islands Data Protection Act 2017 (DPA)
3 source controls mapped|3 target controls covered
5%
Fiji Data Protection Bill (2020)
3 source controls mapped|2 target controls covered
5%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|2 target controls covered
5%
Danish Data Protection Act (Databeskyttelsesloven)
3 source controls mapped|2 target controls covered
5%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
3 source controls mapped|1 target controls covered
5%
Ghana Data Protection Act 2012 (Act 843)
3 source controls mapped|2 target controls covered
5%
Student Privacy Pledge 2020
3 source controls mapped|1 target controls covered
5%
Myanmar Cybersecurity Law (2023)
3 source controls mapped|1 target controls covered
5%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|2 target controls covered
5%
Jordan Draft Personal Data Protection Law (2022)
3 source controls mapped|3 target controls covered
5%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
5%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
5%
Canada's Anti-Spam Legislation (CASL)
3 source controls mapped|1 target controls covered
5%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
3 source controls mapped|1 target controls covered
5%
South Africa Promotion of Access to Information Act (PAIA)
3 source controls mapped|2 target controls covered
5%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|2 target controls covered
5%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|3 target controls covered
5%
ISO 26000:2010
3 source controls mapped|1 target controls covered
5%
Tonga Communications Act (2015) - Privacy & Data Protection
3 source controls mapped|1 target controls covered
5%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|2 target controls covered
4%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|4 target controls covered
4%
CWE Top 25 Most Dangerous Software Weaknesses (2024)
2 source controls mapped|6 target controls covered
4%
AML/CTF Act 2006 (Australia)
2 source controls mapped|2 target controls covered
4%
OWASP Top 10 for LLM Applications 2025
2 source controls mapped|4 target controls covered
4%
ISO/IEC 42001:2023
2 source controls mapped|1 target controls covered
4%
ISO 31000:2018
2 source controls mapped|2 target controls covered
4%
NIST SP 800-34 Rev 1 - Contingency Planning Guide
2 source controls mapped|1 target controls covered
4%
APRA CPS 234
2 source controls mapped|1 target controls covered
4%
BCBS 239
2 source controls mapped|1 target controls covered
4%
NSA CNSA Suite 2.0 - Commercial National Security Algorithm Suite
2 source controls mapped|3 target controls covered
4%
AICPA SOC 1
2 source controls mapped|1 target controls covered
4%
NATO STANAG 4774/4778 - Confidentiality Metadata Labels
2 source controls mapped|2 target controls covered
4%
NSA Quantum-Resistant (QR) Cryptography Migration Guidance
2 source controls mapped|3 target controls covered
4%
ENISA Privacy‑Enhancing Technologies (PET) reports and recommendations
2 source controls mapped|2 target controls covered
4%
GLBA
2 source controls mapped|1 target controls covered
4%
PCI P2PE
2 source controls mapped|1 target controls covered
4%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|5 target controls covered
4%
Open Banking Security
2 source controls mapped|1 target controls covered
4%
PSD2 SCA
2 source controls mapped|1 target controls covered
4%
SWIFT CSP
2 source controls mapped|1 target controls covered
4%
OSFI B-13
2 source controls mapped|1 target controls covered
4%
MAS TRM
2 source controls mapped|1 target controls covered
4%
TIBER-EU (Threat Intelligence-Based Ethical Red Teaming - European Union)
2 source controls mapped|1 target controls covered
4%
PCI SSF
2 source controls mapped|1 target controls covered
4%
HKMA SPM
2 source controls mapped|1 target controls covered
4%
FFIEC IT Examination Handbook
2 source controls mapped|1 target controls covered
4%
PCI PIN Security
2 source controls mapped|1 target controls covered
4%
AICPA SOC 3
2 source controls mapped|1 target controls covered
4%
Canada Artificial Intelligence and Data Act (AIDA)
2 source controls mapped|2 target controls covered
4%
Notifiable Data Breaches Scheme (Australia)
2 source controls mapped|4 target controls covered
4%
FTC Health Breach Notification Rule
2 source controls mapped|4 target controls covered
4%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
2 source controls mapped|4 target controls covered
4%
European Accessibility Act (Directive (EU) 2019/882)
2 source controls mapped|4 target controls covered
4%
Regulation (EU) 2023/1115 on deforestation-free supply chains
2 source controls mapped|4 target controls covered
4%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
2 source controls mapped|4 target controls covered
4%
NIS2 Directive (Directive (EU) 2022/2555)
2 source controls mapped|4 target controls covered
4%
US SEC Digital Assets and Crypto Regulatory Framework
2 source controls mapped|4 target controls covered
4%
Australia eSafety Commissioner - Online Safety Expectations for Industry
2 source controls mapped|4 target controls covered
4%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
2 source controls mapped|4 target controls covered
4%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
2 source controls mapped|3 target controls covered
4%
Australia IRAP - Information Security Registered Assessors Program
2 source controls mapped|2 target controls covered
4%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
2 source controls mapped|2 target controls covered
4%
US NRC 10 CFR 73.54 - Cyber Security for Nuclear Power Plants
2 source controls mapped|1 target controls covered
4%
SWIFT CSCF v2024
1 source controls mapped|1 target controls covered
2%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
1 source controls mapped|1 target controls covered
2%
EN 301 549 - ICT Accessibility Requirements
1 source controls mapped|1 target controls covered
2%
Regulation on the European Health Data Space (EHDS)
1 source controls mapped|1 target controls covered
2%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
1 source controls mapped|1 target controls covered
2%
EU Payment Services Directive (PSD2)
1 source controls mapped|3 target controls covered
2%
WCAG 2.2
1 source controls mapped|2 target controls covered
2%
FIDO2 / WebAuthn - Passwordless Authentication Standard
1 source controls mapped|3 target controls covered
2%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27014:2020
1 source controls mapped|2 target controls covered
2%
Equator Principles (EP4, 2020)
1 source controls mapped|1 target controls covered
2%
COSO Enterprise Risk Management (ERM) - Integrated Framework
1 source controls mapped|3 target controls covered
2%
APRA CPS 220 Risk Management
1 source controls mapped|1 target controls covered
2%
Colorado Artificial Intelligence Act (proposed SB 24-205)
1 source controls mapped|1 target controls covered
2%
SQF Code Edition 9 - Safe Quality Food
1 source controls mapped|2 target controls covered
2%
TNFD Recommendations
1 source controls mapped|1 target controls covered
2%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|2 target controls covered
2%
EU Digital Services Act
1 source controls mapped|2 target controls covered
2%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|1 target controls covered
2%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
2%
India CERT-In Cyber Security Directions 2022
1 source controls mapped|1 target controls covered
2%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
1 source controls mapped|1 target controls covered
2%
EN 50126, EN 50128, and EN 50129 - Railway Applications - Reliability, Availability, Maintainability and Safety (RAMS)
1 source controls mapped|2 target controls covered
2%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
2%
CDP (formerly Carbon Disclosure Project)
1 source controls mapped|3 target controls covered
2%
GAMP 5 - Good Automated Manufacturing Practice
1 source controls mapped|3 target controls covered
2%
AASB S2 Climate-related Disclosures
1 source controls mapped|3 target controls covered
2%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
1 source controls mapped|2 target controls covered
2%
EU NIS2 Directive - Transport Sector Requirements
1 source controls mapped|1 target controls covered
2%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
2%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
2%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|3 target controls covered
2%
Japan FSA Cybersecurity Guidelines for Financial Institutions
1 source controls mapped|3 target controls covered
2%
Kuwait National Cybersecurity Framework
1 source controls mapped|3 target controls covered
2%
UK Online Safety Act 2023
1 source controls mapped|3 target controls covered
2%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|2 target controls covered
2%
NIST SP 800-30
1 source controls mapped|3 target controls covered
2%
ISO 31000
1 source controls mapped|3 target controls covered
2%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
1 source controls mapped|3 target controls covered
2%
AS9100D - Aerospace Quality Management System
1 source controls mapped|2 target controls covered
2%
ISO/IEC 27003:2017
1 source controls mapped|2 target controls covered
2%
ISO 22000
1 source controls mapped|1 target controls covered
2%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|1 target controls covered
2%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|3 target controls covered
2%
NIST SP 800-37
1 source controls mapped|3 target controls covered
2%
ISO 45001
1 source controls mapped|1 target controls covered
2%
ISO 41001:2018 - Facility Management Systems
1 source controls mapped|1 target controls covered
2%
ISO 39001:2012 - Road Traffic Safety Management
1 source controls mapped|1 target controls covered
2%
ISO 50001:2018 - Energy Management Systems
1 source controls mapped|1 target controls covered
2%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|1 target controls covered
2%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|2 target controls covered
2%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|2 target controls covered
2%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|2 target controls covered
2%
NERC CIP
1 source controls mapped|1 target controls covered
2%
MTCS - Multi-Tier Cloud Security (Singapore)
1 source controls mapped|1 target controls covered
2%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|2 target controls covered
2%
FedRAMP High
1 source controls mapped|2 target controls covered
2%
NIST SP 800-53 Revision 5.1 HIGH
1 source controls mapped|2 target controls covered
2%
IRS Publication 1075
1 source controls mapped|2 target controls covered
2%
FedRAMP Moderate
1 source controls mapped|2 target controls covered
2%
NIST SP 800-53 Rev 5 MODERATE
1 source controls mapped|2 target controls covered
2%
NIST SP 800-53 Rev 5 LOW
1 source controls mapped|2 target controls covered
2%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|3 target controls covered
2%
NIST SP 800-39
1 source controls mapped|3 target controls covered
2%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|1 target controls covered
2%
IATF 16949:2016 - Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
2%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
2%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|1 target controls covered
2%
ISO 26262:2018 - Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
2%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
2%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|1 target controls covered
2%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
2%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
2%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
2%
FIRST CSIRT Services Framework and Standards
1 source controls mapped|1 target controls covered
2%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
2%
Aged Care Quality Standards (Australia)
1 source controls mapped|1 target controls covered
2%
China Cybersecurity Law (CSL)
1 source controls mapped|1 target controls covered
2%
ICH E6(R3) - Good Clinical Practice
1 source controls mapped|1 target controls covered
2%
FATF 40 Recommendations
1 source controls mapped|1 target controls covered
2%
ISO/IEC 25012:2008 - Data Quality Model
1 source controls mapped|1 target controls covered
2%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
1 source controls mapped|1 target controls covered
2%
GHG Protocol
1 source controls mapped|1 target controls covered
2%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
2%
Samoa Telecommunications Act (2005) - Privacy & Data Protection
1 source controls mapped|2 target controls covered
2%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|1 target controls covered
2%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
1 source controls mapped|1 target controls covered
2%
EU Markets in Crypto-Assets Regulation (MiCA)
1 source controls mapped|3 target controls covered
2%
ISO/IEC 27006:2024
1 source controls mapped|1 target controls covered
2%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
1 source controls mapped|1 target controls covered
2%
ITAR - International Traffic in Arms Regulations
1 source controls mapped|2 target controls covered
2%
Frequently Asked Questions
What is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 is a compliance framework from United States with 12 domains and 57 controls. Electronic Records; Electronic Signatures (pharmaceutical/medical devices) It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does FDA 21 CFR Part 11 have?
FDA 21 CFR Part 11 has 57 controls organised across 12 domains. The largest domains are Electronic Signature (16 controls), Closed System (6 controls), FDA 21 CFR Part 11: Administrative Safeguards (6 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does FDA 21 CFR Part 11 map to?
FDA 21 CFR Part 11 maps to 567 other compliance frameworks. The top mapping partners are NIS2 Directive Implementing Acts (19% coverage), ISO 13485 (19% coverage), UK Telecommunications (Security) Act 2021 (19% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with FDA 21 CFR Part 11 compliance?
Start your FDA 21 CFR Part 11 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about FDA 21 CFR Part 11 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 57 controls and track your progress.
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