21 CFR Part 58 — Good Laboratory Practice (GLP)

United States

vCurrent (as amended)

7 domains

31 controls

Title 21 Code of Federal Regulations Part 58 establishes Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies supporting applications for research or marketing permits for FDA-regulated products. Covers organization, facilities, equipment, testing operations, records, and reporting requirements to ensure the quality and integrity of safety data.

Verified

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Framework Domains (7)

Disqualification of Testing Facilities (Subpart K)

4 controls

Controls in the Disqualification of Testing Facilities (Subpart K) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 4 controls
Code	Title	Description
58.200	Purpose of Disqualification	Establishes the purpose and criteria for disqualifying noncompliant testing facilities.
58.202	Grounds for Disqualification	A facility may be disqualified upon FDA finding of repeated failures to comply with GLP requirements.
58.206	Final Order on Disqualification	FDA Commissioner issues final order after hearing, precluding facility from conducting future studies.
58.219	Reinstatement of Disqualified Facility	Disqualified facilities may be reinstated upon demonstrating compliance with GLP requirements.

Equipment and Operations (Subparts D & E)

5 controls

Controls in the Equipment and Operations (Subparts D & E) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 5 controls
Code	Title	Description
58.61	Equipment Design	Equipment must be of appropriate design and adequate capacity for its intended use.
58.63	Maintenance and Calibration	Equipment must be adequately inspected, cleaned, maintained, tested, and calibrated with written records.
58.81	Standard Operating Procedures	Written SOPs must be established and followed for all routine laboratory methods and operations.
58.83	Reagents and Solutions	All reagents and solutions must be labeled with identity, titer, storage requirements, and expiration date.
58.90	Animal Care	Proper procedures must be established for animal housing, feeding, handling, and disease diagnosis.

Facilities (Subpart C)

6 controls

Controls in the Facilities (Subpart C) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 6 controls
Code	Title	Description
58.41	General Facility Requirements	Testing facilities must be of suitable size, construction, and location to meet protocol requirements.
58.43	Animal Care Facilities	Animal care areas must provide proper separation, environmental controls, and housing conditions.
58.45	Animal Supply Facilities	Facilities for animal receipt and storage must have adequate quarantine and isolation areas.
58.47	Test and Control Article Handling Facilities	Separate areas must be provided for receipt, storage, mixing, and handling of test and control articles.
58.49	Laboratory Operation Areas	Laboratories must be separated to prevent cross-contamination and provide suitable conditions for operations.
58.51	Specimen and Data Storage	Adequate facilities must be provided for specimen and data storage to prevent deterioration or loss.

General Provisions (Subpart A)

4 controls

Controls in the General Provisions (Subpart A) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 4 controls
Code	Title	Description
58.1	Scope	Defines the scope of GLP regulations for nonclinical laboratory studies supporting FDA applications.
58.10	Applicability to Grants and Contracts	Establishes that GLP requirements apply to studies performed under grants and contracts.
58.15	Inspection of Testing Facility	Authorizes FDA to inspect testing facilities to verify GLP compliance at reasonable times.
58.3	Definitions	Provides definitions of key terms used throughout the regulation including study director, sponsor, and test article.

Organization and Personnel (Subpart B)

4 controls

Controls in the Organization and Personnel (Subpart B) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 4 controls
Code	Title	Description
58.29	Personnel Qualifications	Requires that personnel have the education, training, and experience to perform assigned functions.
58.31	Testing Facility Management	Management must designate a study director, ensure qualified personnel, and assure GLP compliance.
58.33	Study Director Responsibilities	Study director has overall responsibility for the technical conduct, interpretation, and reporting of the study.
58.35	Quality Assurance Unit	Requires an independent QAU to monitor studies and inspect facilities for GLP compliance.

Records and Reports (Subpart J)

3 controls

Controls in the Records and Reports (Subpart J) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 3 controls
Code	Title	Description
58.185	Reporting of Study Results	Final reports must include study objectives, methods, results, and a signed QAU compliance statement.
58.190	Storage and Retrieval of Records	All study data, documentation, protocols, and reports must be stored and readily retrievable.
58.195	Retention of Records	Records must be retained for specified periods depending on the nature of the study and regulatory requirements.

Test Articles and Protocol (Subparts F & G)

5 controls

Controls in the Test Articles and Protocol (Subparts F & G) domain of 21 CFR Part 58 — Good Laboratory Practice (GLP) — 5 controls
Code	Title	Description
58.105	Test and Control Article Characterization	Test articles must be characterized for identity, strength, purity, composition, and stability.
58.107	Test Article Handling	Procedures must ensure proper identification, handling, and accountability of test and control articles.
58.113	Mixtures of Articles with Carriers	Uniformity, concentration, and stability of test article mixtures with carriers must be determined.
58.120	Protocol Requirements	Each study must have an approved written protocol with objectives, methods, and statistical analysis plans.
58.130	Conduct of Study	Studies must be conducted in accordance with the protocol, with deviations documented and authorized.

Maps to 422 other frameworks

31 total controls

NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements

4 source controls mapped|7 target controls covered

13%

NIS2 Directive Implementing Acts

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UK Telecommunications (Security) Act 2021

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ISO/IEC 27011:2024

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FedRAMP Rev 5

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ISO/IEC 27400:2022

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CFTC System Safeguards (17 CFR 37, 38, 39, 49)

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SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)

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

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PCI DSS v4.0

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UK Gambling Commission — Cyber Resilience Requirements

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PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments

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Canada ITSG-33 — IT Security Risk Management

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New Zealand Information Security Manual (NZISM)

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MARS-E — Minimum Acceptable Risk Standards for Exchanges

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South Korea Cloud Security Assurance Program (CSAP)

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NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity

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Defence Security Principles Framework (DSPF)

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Protective Security Policy Framework (PSPF) Release 2024

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Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)

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ISO 28001:2007 Supply Chain Security Management

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SOC 2

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NAIC Insurance Data Security Model Law (MDL-668)

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NIST SP 800-82 Rev 3 — Guide to OT Security

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IRS Publication 1075 — Tax Information Security Guidelines

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SSAE 18 — Attestation Standards (SOC Reporting)

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SWIFT Customer Security Programme (CSP)

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EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)

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NIST Cybersecurity Framework 2.0

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IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)

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GLI-33 — Gaming Laboratories International Event Wagering Systems

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EIOPA Guidelines on ICT Security and Governance (2020)

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TISAX — Trusted Information Security Assessment Exchange

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Telecommunications Sector Security Reforms (TSSR)

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CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines

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FBI CJIS Security Policy

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BRCGS Global Standard for Food Safety Issue 9

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FDA Quality Management System Regulation (QMSR)

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3GPP Security Architecture (TS 33.501 — 5G Security)

3 source controls mapped|7 target controls covered

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

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AS9100D — Aerospace Quality Management System

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ISO/IEC 27003:2017

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ASIS SPC.1-2009 — Organizational Resilience Standard

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DO-178C / ED-12C — Software Considerations in Airborne Systems

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PIC/S Guide to Good Manufacturing Practice for Medicinal Products

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ISO/IEC 27006:2024

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

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ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence

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IEC 62304:2015 Medical Device Software Lifecycle Processes

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SQF Code Edition 9 — Safe Quality Food

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US OFAC Sanctions Compliance Framework

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21 CFR Part 211 — Current Good Manufacturing Practice

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ISO/IEC 25012:2008 — Data Quality Model

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C-TPAT — Customs-Trade Partnership Against Terrorism

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WCO Authorised Economic Operator (AEO) Framework

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NRF Cybersecurity and Data Privacy Framework (National Retail Federation)

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WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)

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Customs-Trade Partnership Against Terrorism (C-TPAT)

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EU Critical Raw Materials Act (Regulation (EU) 2024/1252)

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EU Chips Act (Regulation (EU) 2023/1781)

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EMV 3-D Secure (3DS2) — Payment Authentication Protocol

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ISO/IEC 29147:2018

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ISO/IEC 29134:2023

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ISO/IEC 27014:2020

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US Foreign Corrupt Practices Act (FCPA)

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ISO/IEC 27557:2022 — Organisational Privacy Risk Management

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ISO/IEC 23837 — Security Requirements for Quantum Key Distribution

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ISO/IEC 29115:2023 — Entity Authentication Assurance Framework

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ISO/IEC 27031:2011

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ISO/IEC 27007:2020

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ISO/IEC 29100:2024

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ISO/IEC 27004:2016

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

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ISO/IEC 30111:2019

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ISO/IEC 38500:2024 — Governance of IT

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3GPP Security

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NIST SP 800-124 Rev 2 — Mobile Device Security

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Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)

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Vietnam Law on Cybersecurity (No. 24/2018/QH14)

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EN 50126/50128/50129 — Railway RAMS and Safety

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FAA Cybersecurity Framework for Aviation

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

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Japan FSA Cybersecurity Guidelines for Financial Institutions

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RBI Cybersecurity Framework for Banks

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Kuwait National Cybersecurity Framework

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Singapore Payment Services Act (PSA) — Digital Payment Token Regulation

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Tanzania Personal Data Protection Act (Draft)

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Kenya Data Protection Act 2019

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Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)

2 source controls mapped|7 target controls covered

Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)

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Brunei Personal Data Protection Order 2024 (PDPO)

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IATF 16949:2016 — Quality Management System for Automotive Production

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NIST SP 800-115

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ISO 27018

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Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)

2 source controls mapped|1 target controls covered

EDM Council CDMC — Cloud Data Management Capabilities Framework

2 source controls mapped|3 target controls covered

HL7 FHIR Security Framework

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OWASP Top 10:2025

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ITAR — International Traffic in Arms Regulations

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ISO 27017

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South Korea PIPA

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Bermuda Personal Information Protection Act 2016 (PIPA)

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China Personal Information Protection Law (PIPL)

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EU Data Act

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TEFCA — Trusted Exchange Framework and Common Agreement

2 source controls mapped|1 target controls covered

ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems

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Science Based Targets initiative (SBTi) Corporate Standard

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UK GDPR (UK General Data Protection Regulation)

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Australia My Health Records Act 2012

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W3C Verifiable Credentials (VC) Data Model 2.0

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FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)

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NIST SP 800-150

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NIST SP 800-34 Rev 1 — Contingency Planning Guide

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NIST AI Risk Management Framework (AI RMF 1.0)

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NIST AI 600-1 Generative AI Profile

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ISO 37000:2021 — Governance of Organizations

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South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics

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Armenia Law on Protection of Personal Data (2015)

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Singapore Cybersecurity Act 2018

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Cyber Security Act 2024 (Australia)

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Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)

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Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)

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Angola Personal Data Protection Law (Law No. 22/11)

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EDM Council DCAM — Data Management Capability Assessment Model

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ISO 8000 — Data Quality

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NIST SP 800-218

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ISMAP (Japan)

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EU Markets in Crypto-Assets Regulation (MiCA)

2 source controls mapped|5 target controls covered

NATO STANAG 4774/4778 — Confidentiality Metadata Labels

2 source controls mapped|3 target controls covered

ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems

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ECB TIBER-EU Framework

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ECB TIBER-EU

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ICH Q10 — Pharmaceutical Quality System

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MITRE ATT&CK

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Sri Lanka Personal Data Protection Act (No. 9 of 2022)

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COSO Enterprise Risk Management (ERM) Framework (2017)

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Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)

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Australia Online Safety Act 2021

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Trinidad and Tobago Data Protection Act 2011

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Jamaica Data Protection Act 2020

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Mauritius Data Protection Act 2017

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Ghana Data Protection Act 2012 (Act 843)

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Cayman Islands Data Protection Act 2017 (DPA)

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Botswana Data Protection Act (2024)

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Malta Data Protection Act (Cap. 586, 2018)

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Fiji Data Protection Bill (2020)

2 source controls mapped|5 target controls covered

Zimbabwe Data Protection Act (2021)

2 source controls mapped|4 target controls covered

Uganda Data Protection and Privacy Act (2019)

2 source controls mapped|4 target controls covered

Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)

2 source controls mapped|6 target controls covered

Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)

2 source controls mapped|5 target controls covered

Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)

2 source controls mapped|5 target controls covered

Finland Data Protection Act (Tietosuojalaki, 1050/2018)

2 source controls mapped|5 target controls covered

Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)

2 source controls mapped|4 target controls covered

Russia Federal Law on Personal Data (152-FZ)

2 source controls mapped|4 target controls covered

UK Construction (Design and Management) Regulations 2015 (CDM 2015)

2 source controls mapped|3 target controls covered

Denmark Data Protection Act (Databeskyttelsesloven, 2018)

2 source controls mapped|4 target controls covered

Laos Law on Prevention and Combating Cybercrime (2015)

2 source controls mapped|4 target controls covered

French Sapin II Law (Law No. 2016-1691)

2 source controls mapped|1 target controls covered

South Africa Promotion of Access to Information Act (PAIA)

2 source controls mapped|1 target controls covered

Sweden Data Protection Act (Dataskyddslag, 2018:218)

2 source controls mapped|1 target controls covered

ISO 20400:2017 — Sustainable Procurement

2 source controls mapped|2 target controls covered

MAS TRM

2 source controls mapped|1 target controls covered

Israel Protection of Privacy Law (5741-1981)

2 source controls mapped|3 target controls covered

SSDF (NIST)

2 source controls mapped|1 target controls covered

PCI PIN Security

2 source controls mapped|1 target controls covered

ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)

2 source controls mapped|3 target controls covered

EU PSD3 and Payment Services Regulation (Proposed)

2 source controls mapped|3 target controls covered

GAMP 5 — Good Automated Manufacturing Practice

2 source controls mapped|2 target controls covered

Philippines Cybercrime Prevention Act (RA 10175)

2 source controls mapped|1 target controls covered

AICPA SOC 3

2 source controls mapped|1 target controls covered

MTCS — Multi-Tier Cloud Security (Singapore)

2 source controls mapped|2 target controls covered

IEC 60601-1 — Medical Electrical Equipment Safety

2 source controls mapped|2 target controls covered

SWIFT CSCF

2 source controls mapped|1 target controls covered

DORA

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Singapore Government Instruction Manual on ICT&SS Management (IM8)

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TNFD Recommendations

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AASB S2 Climate-related Disclosures

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US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants

2 source controls mapped|3 target controls covered

3GPP 5G Security Architecture (TS 33.501)

2 source controls mapped|2 target controls covered

ISO/IEC 23894:2023

2 source controls mapped|3 target controls covered

ECSS Software Engineering Standards (ESA)

2 source controls mapped|3 target controls covered

DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)

2 source controls mapped|3 target controls covered

US SEC Digital Assets and Crypto Regulatory Framework

2 source controls mapped|3 target controls covered

Digital Economy Partnership Agreement (DEPA)

2 source controls mapped|2 target controls covered

Online Safety Act 2021 (Australia)

2 source controls mapped|3 target controls covered

UK Building Safety Act 2022

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ISO/SAE 21434

2 source controls mapped|1 target controls covered

ESA ECSS-E-ST-40C — Space Software Engineering Standard

2 source controls mapped|3 target controls covered

Nigeria Data Protection Act 2023 (NDPA)

2 source controls mapped|2 target controls covered

Azerbaijan Law on Personal Data (2010)

2 source controls mapped|1 target controls covered

CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0

2 source controls mapped|1 target controls covered

DFARS 252.204-7012 — Safeguarding Covered Defense Information

2 source controls mapped|3 target controls covered

Connecticut Data Privacy Act (CTDPA)

2 source controls mapped|3 target controls covered

Illinois Biometric Information Privacy Act (BIPA)

2 source controls mapped|3 target controls covered

Modern Slavery Act 2018 (Australia)

2 source controls mapped|3 target controls covered

Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)

2 source controls mapped|3 target controls covered

Wisconsin Data Privacy Act (SB 670)

2 source controls mapped|3 target controls covered

Florida Digital Bill of Rights (FDBR)

2 source controls mapped|3 target controls covered

OWASP DevSecOps Maturity Model (DSOMM)

2 source controls mapped|3 target controls covered

CSA STAR (Security, Trust, Assurance, and Risk)

2 source controls mapped|2 target controls covered

EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)

2 source controls mapped|4 target controls covered

OWASP MASVS

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OWASP ASVS

2 source controls mapped|1 target controls covered

China Cybersecurity Law (CSL)

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Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)

2 source controls mapped|4 target controls covered

Paraguay Law on Protection of Personal Data (Law No. 6534/2020)

2 source controls mapped|4 target controls covered

Jordan Draft Personal Data Protection Law (2022)

2 source controls mapped|4 target controls covered

South Korea Personal Information Protection Act (PIPA)

2 source controls mapped|5 target controls covered

Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)

2 source controls mapped|5 target controls covered

Portugal Law No. 58/2019 — Data Protection Implementation Act

2 source controls mapped|6 target controls covered

Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)

2 source controls mapped|6 target controls covered

Montenegro Law on Personal Data Protection (2023)

2 source controls mapped|6 target controls covered

North Macedonia Law on Personal Data Protection (2020)

2 source controls mapped|5 target controls covered

Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)

2 source controls mapped|6 target controls covered

Japan Act on Specified Commercial Transactions (ASCT) — Digital Services

2 source controls mapped|5 target controls covered

EU Product Liability Directive (Directive (EU) 2024/2853)

2 source controls mapped|6 target controls covered

EU Platform Work Directive (Directive 2024/2831)

2 source controls mapped|6 target controls covered

EU Pay Transparency Directive (Directive 2023/970)

2 source controls mapped|6 target controls covered

Uruguay Personal Data Protection Act (Law No. 18.331)

2 source controls mapped|5 target controls covered

EU Clinical Trials Regulation (CTR 536/2014)

2 source controls mapped|1 target controls covered

Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)

2 source controls mapped|2 target controls covered

ISO 22320:2018

2 source controls mapped|3 target controls covered

CAIQ (CSA)

2 source controls mapped|1 target controls covered

RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)

2 source controls mapped|3 target controls covered

C5 (Germany)

2 source controls mapped|1 target controls covered

EU GMP Annex 11 — Computerised Systems

2 source controls mapped|3 target controls covered

ITU Radio Regulations and Space Security Standards

2 source controls mapped|1 target controls covered

NIST SP 800-207

2 source controls mapped|1 target controls covered

O-RAN Alliance Security Specifications (O-RAN.WG11)

2 source controls mapped|3 target controls covered

UK Bribery Act 2010

2 source controls mapped|3 target controls covered

Pakistan Personal Data Protection Bill 2023

2 source controls mapped|3 target controls covered

ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)

2 source controls mapped|3 target controls covered

Egypt Personal Data Protection Law (Law No. 151 of 2020)

2 source controls mapped|6 target controls covered

ICAO Annex 17 — Aviation Security (AVSEC)

2 source controls mapped|3 target controls covered

EU Carbon Border Adjustment Mechanism (CBAM)

2 source controls mapped|4 target controls covered

EU Cyber Solidarity Act (Regulation (EU) 2025/38)

2 source controls mapped|4 target controls covered

EU Digital Services Act — Online Gaming Platform Requirements

2 source controls mapped|1 target controls covered

EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)

2 source controls mapped|3 target controls covered

EU European Media Freedom Act (EMFA)

2 source controls mapped|5 target controls covered

EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity

2 source controls mapped|5 target controls covered

EU Seveso III Directive (Directive 2012/18/EU)

2 source controls mapped|5 target controls covered

EU Taxonomy Regulation (Regulation 2020/852)

2 source controls mapped|4 target controls covered

EU Taxonomy for Sustainable Activities (Regulation 2020/852)

2 source controls mapped|2 target controls covered

eIDAS 2.0 — EU Digital Identity Regulation

2 source controls mapped|3 target controls covered

Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)

2 source controls mapped|3 target controls covered

MiFID II / MiFIR

2 source controls mapped|1 target controls covered

Rwanda Law No. 058/2021 Relating to the Protection of Personal Data

2 source controls mapped|4 target controls covered

Costa Rica Personal Data Protection Law (Law No. 8968)

2 source controls mapped|4 target controls covered

Turkey Personal Data Protection Law (KVKK — Law No. 6698)

2 source controls mapped|4 target controls covered

Ethiopia Personal Data Protection Proclamation (No. 1321/2024)

2 source controls mapped|4 target controls covered

Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)

2 source controls mapped|3 target controls covered

Kazakhstan Law on Personal Data and Their Protection (No. 94-V)

2 source controls mapped|4 target controls covered

Uzbekistan Law on Personal Data (No. ZRU-547)

2 source controls mapped|4 target controls covered

Georgia Law on Personal Data Protection (2012)

2 source controls mapped|4 target controls covered

Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)

2 source controls mapped|4 target controls covered

Panama Law on Personal Data Protection (Law No. 81 of 2019)

2 source controls mapped|4 target controls covered

Serbia Law on Personal Data Protection (2018)

2 source controls mapped|4 target controls covered

Lithuania Law on Legal Protection of Personal Data (2018)

2 source controls mapped|2 target controls covered

Oman Personal Data Protection Law (Royal Decree 6/2022)

2 source controls mapped|4 target controls covered

Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)

2 source controls mapped|4 target controls covered

UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)

2 source controls mapped|4 target controls covered

ASEAN Data Management Framework

2 source controls mapped|2 target controls covered

Brazil Open Finance (Resolução Conjunta No. 1/2020)

2 source controls mapped|5 target controls covered

Australia NHMRC National Statement on Ethical Conduct in Human Research

2 source controls mapped|2 target controls covered

PCI P2PE

2 source controls mapped|1 target controls covered

ASIC Cyber Resilience Good Practices

2 source controls mapped|2 target controls covered

Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions

2 source controls mapped|1 target controls covered

ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary

2 source controls mapped|3 target controls covered

OCC Heightened Standards (12 CFR Part 30, Appendix D)

2 source controls mapped|1 target controls covered

HKMA Cyber Resilience Assessment Framework (C-RAF)

2 source controls mapped|2 target controls covered

NIST SP 800-88

2 source controls mapped|1 target controls covered

California IoT Security Law

2 source controls mapped|1 target controls covered

India Account Aggregator Framework (RBI)

2 source controls mapped|1 target controls covered

APRA Prudential Standard CPS 234 — Information Security (Australia)

2 source controls mapped|1 target controls covered

ISO 56002

2 source controls mapped|4 target controls covered

UK Open Banking Standard

2 source controls mapped|1 target controls covered

FATF Recommendation 16 — Virtual Asset Travel Rule

2 source controls mapped|2 target controls covered

BCBS 239

2 source controls mapped|1 target controls covered

EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)

2 source controls mapped|2 target controls covered

South Korea Credit Information Act

2 source controls mapped|1 target controls covered

Virginia Consumer Data Protection Act (VCDPA)

2 source controls mapped|1 target controls covered

NIST SP 800-181

2 source controls mapped|1 target controls covered

OSFI B-13

2 source controls mapped|1 target controls covered

Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)

2 source controls mapped|1 target controls covered

NIST SP 800-146

2 source controls mapped|1 target controls covered

FTC GLBA Safeguards Rule (16 CFR Part 314)

2 source controls mapped|2 target controls covered

CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)

2 source controls mapped|1 target controls covered

ASD Information Security Manual (ISM)

2 source controls mapped|1 target controls covered

ILO Nursing Personnel Convention C149 (1977)

2 source controls mapped|3 target controls covered

EU ePrivacy Directive (2002/58/EC)

2 source controls mapped|4 target controls covered

IFRS 17 — Insurance Contracts

2 source controls mapped|2 target controls covered

FTC Health Breach Notification Rule

2 source controls mapped|3 target controls covered

CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)

2 source controls mapped|3 target controls covered

AICPA Privacy Management Framework (PMF)

2 source controls mapped|2 target controls covered

NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)

2 source controls mapped|1 target controls covered

Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct

2 source controls mapped|1 target controls covered

BREEAM — Building Research Establishment Environmental Assessment Method

2 source controls mapped|1 target controls covered

EU Taxonomy Regulation

2 source controls mapped|3 target controls covered

IAIS Insurance Core Principles (ICPs)

2 source controls mapped|1 target controls covered

EU Cyber Resilience Act

2 source controls mapped|1 target controls covered

ISO 41001:2018 — Facility Management Systems

2 source controls mapped|3 target controls covered

ISO 39001:2012 — Road Traffic Safety Management

2 source controls mapped|3 target controls covered

ISO 37002:2021 — Whistleblowing Management Systems

2 source controls mapped|3 target controls covered

ISO 50001:2018 — Energy Management Systems

2 source controls mapped|3 target controls covered

ISO 22313:2020 — Guidance on Business Continuity Management Systems

2 source controls mapped|3 target controls covered

Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter

2 source controls mapped|2 target controls covered

EU AI Liability Directive

2 source controls mapped|4 target controls covered

EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)

2 source controls mapped|5 target controls covered

EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)

2 source controls mapped|2 target controls covered

Cook Islands Electronic Transactions Act & Privacy Provisions (2003)

2 source controls mapped|3 target controls covered

US Americans with Disabilities Act (ADA) — Title III Digital Accessibility

2 source controls mapped|3 target controls covered

EU Network Code on Cybersecurity for the Electricity Sector

2 source controls mapped|3 target controls covered

EU Machinery Regulation (Regulation (EU) 2023/1230)

2 source controls mapped|4 target controls covered

EU General Product Safety Regulation (GPSR, Regulation 2023/988)

2 source controls mapped|5 target controls covered

EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)

2 source controls mapped|3 target controls covered

EU In Vitro Diagnostic Medical Devices Regulation (IVDR)

2 source controls mapped|2 target controls covered

EU Web Accessibility Directive (Directive 2016/2102)

2 source controls mapped|3 target controls covered

African Union Malabo Convention

2 source controls mapped|3 target controls covered

Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)

2 source controls mapped|2 target controls covered

Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)

2 source controls mapped|2 target controls covered

Senegal Law on Personal Data Protection (Law No. 2008-12)

2 source controls mapped|3 target controls covered

Morocco Data Protection Law (09-08)

2 source controls mapped|4 target controls covered

Peru Personal Data Protection Law (Law No. 29733)

2 source controls mapped|3 target controls covered

Ukraine Law on Personal Data Protection (Law No. 2297-VI)

2 source controls mapped|3 target controls covered

Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)

2 source controls mapped|3 target controls covered

Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act

2 source controls mapped|2 target controls covered

Privacy by Design (PbD) — Seven Foundational Principles

2 source controls mapped|1 target controls covered

BS 65000:2014 — Guidance on Organizational Resilience

2 source controls mapped|1 target controls covered

Notifiable Data Breaches Scheme (Australia)

2 source controls mapped|2 target controls covered

EU Digital Markets Act

2 source controls mapped|1 target controls covered

UK Product Security and Telecommunications Infrastructure Act (PSTI)

2 source controls mapped|1 target controls covered

EAR — Export Administration Regulations

2 source controls mapped|1 target controls covered

European Accessibility Act (Directive (EU) 2019/882)

2 source controls mapped|1 target controls covered

EU Deforestation-Free Products Regulation (EUDR)

2 source controls mapped|1 target controls covered

Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard

2 source controls mapped|1 target controls covered

EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)

2 source controls mapped|1 target controls covered

US ITAR and EAR — Export Control and Data Security

2 source controls mapped|1 target controls covered

Australia Consumer Data Right — Banking (CDR)

2 source controls mapped|1 target controls covered

Australia eSafety Commissioner — Online Safety Expectations for Industry

2 source controls mapped|1 target controls covered

SIG (Shared Assessments)

2 source controls mapped|1 target controls covered

NIST SP 800-145

2 source controls mapped|1 target controls covered

NIST SP 800-61

2 source controls mapped|1 target controls covered

IEC 62351 — Power Systems Communication Security

2 source controls mapped|1 target controls covered

IATA Operational Safety Audit (IOSA) Standards Manual

2 source controls mapped|1 target controls covered

NIST SP 800-144

2 source controls mapped|1 target controls covered

HKMA SPM

2 source controls mapped|1 target controls covered

NIST SP 800-137

2 source controls mapped|1 target controls covered

NIST SP 800-92

2 source controls mapped|1 target controls covered

EU European Health Data Space (EHDS)

2 source controls mapped|1 target controls covered

AWS Well-Architected Security Pillar

2 source controls mapped|1 target controls covered

BSIMM

2 source controls mapped|1 target controls covered

NIST SP 800-183

2 source controls mapped|1 target controls covered

UK PSTI Act

2 source controls mapped|1 target controls covered

SLSA

2 source controls mapped|1 target controls covered

WHO Global Strategy on Digital Health 2020-2025

2 source controls mapped|1 target controls covered

ISO 26262:2018 — Functional Safety for Road Vehicles

2 source controls mapped|1 target controls covered

SANS Incident Handler's Handbook and PICERL Methodology

2 source controls mapped|2 target controls covered

Barbados Data Protection Act 2019

2 source controls mapped|1 target controls covered

PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)

2 source controls mapped|3 target controls covered

SWIFT CSP

2 source controls mapped|1 target controls covered

Automotive SPICE (ASPICE) v4.0 — Process Assessment Model

2 source controls mapped|2 target controls covered

NIST SP 800-128

2 source controls mapped|1 target controls covered

NIST SP 800-63

2 source controls mapped|1 target controls covered

NIST SP 800-160

2 source controls mapped|1 target controls covered

Azure Security Benchmark

2 source controls mapped|1 target controls covered

GLBA

2 source controls mapped|1 target controls covered

APRA CPS 234

2 source controls mapped|1 target controls covered

OpenSSF Scorecard

2 source controls mapped|1 target controls covered

NIST SP 800-190

2 source controls mapped|1 target controls covered

MTCS (Singapore)

2 source controls mapped|1 target controls covered

MITRE D3FEND

2 source controls mapped|1 target controls covered

Tennessee Information Protection Act (TIPA)

2 source controls mapped|1 target controls covered

Chile Personal Data Protection Law (Law No. 21.719)

2 source controls mapped|3 target controls covered

OWASP SAMM

2 source controls mapped|1 target controls covered

ISO 27043

2 source controls mapped|1 target controls covered

WCAG 2.2

2 source controls mapped|1 target controls covered

South Korea ISMS-P

2 source controls mapped|1 target controls covered

NIST SP 800-187

2 source controls mapped|1 target controls covered

NIST SP 800-123

2 source controls mapped|1 target controls covered

US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates

2 source controls mapped|1 target controls covered

IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)

2 source controls mapped|1 target controls covered

Florida Digital Bill of Rights (SB 262)

2 source controls mapped|1 target controls covered

ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)

2 source controls mapped|1 target controls covered

Open Banking Security

2 source controls mapped|1 target controls covered

AICPA SOC 1

2 source controls mapped|1 target controls covered

EU NIS2 Directive — Transport Sector Requirements

2 source controls mapped|2 target controls covered

RICS Professional Standards — Data and Technology in Property

2 source controls mapped|1 target controls covered

UNECE WP.29 R155

2 source controls mapped|1 target controls covered

PTES

2 source controls mapped|1 target controls covered

PCI SSF

2 source controls mapped|1 target controls covered

USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)

2 source controls mapped|1 target controls covered

UNECE WP.29 R156

2 source controls mapped|1 target controls covered

ETSI EN 303 645

2 source controls mapped|1 target controls covered

ISO 27002:2022

2 source controls mapped|1 target controls covered

FFIEC IT Examination Handbook

2 source controls mapped|1 target controls covered

NIST SP 800-161

2 source controls mapped|1 target controls covered

PSD2 SCA

2 source controls mapped|1 target controls covered

COBIT 2019

2 source controls mapped|1 target controls covered

US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements

1 source controls mapped|3 target controls covered

ISO/IEC 27010:2015

1 source controls mapped|1 target controls covered

ISO 27001:2022

1 source controls mapped|2 target controls covered

US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements

1 source controls mapped|1 target controls covered

Critical Infrastructure Risk Management Program (CIRMP) Rules 2023

1 source controls mapped|2 target controls covered

SOC for Cybersecurity — Cybersecurity Risk Management Examination

1 source controls mapped|1 target controls covered

NIST SP 800-53 Rev 5

1 source controls mapped|3 target controls covered

UK Security and Emergency Measures Direction (SEMD) — Water Industry

1 source controls mapped|3 target controls covered

NIST Privacy Framework 1.0

1 source controls mapped|1 target controls covered

Defence Industry Security Program (DISP)

1 source controls mapped|3 target controls covered

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

1 source controls mapped|1 target controls covered

IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems

1 source controls mapped|1 target controls covered

PropTech Security Standards — Smart Building Cybersecurity

1 source controls mapped|1 target controls covered

EN 301 549 — ICT Accessibility Requirements

1 source controls mapped|1 target controls covered

BSI C5 — Cloud Computing Compliance Criteria Catalogue

1 source controls mapped|1 target controls covered

Security of Critical Infrastructure Act 2018 (SOCI)

1 source controls mapped|1 target controls covered

GS1 Global Standards — Supply Chain Traceability and Data Security

1 source controls mapped|2 target controls covered

Singapore Model AI Governance Framework (2nd Edition)

1 source controls mapped|1 target controls covered

EU Medical Devices Regulation (MDR 2017/745)

1 source controls mapped|2 target controls covered

FSSC 22000 — Food Safety System Certification

1 source controls mapped|3 target controls covered

GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6

1 source controls mapped|2 target controls covered

ICH E6(R3) — Good Clinical Practice

1 source controls mapped|1 target controls covered

CDP (formerly Carbon Disclosure Project)

1 source controls mapped|1 target controls covered

EU Digital Services Act

1 source controls mapped|1 target controls covered

Compare 21 CFR Part 58 — Good Laboratory Practice (GLP) with NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements

Frequently Asked Questions

What is 21 CFR Part 58 — Good Laboratory Practice (GLP)?

21 CFR Part 58 — Good Laboratory Practice (GLP) is a compliance framework from United States with 7 domains and 31 controls. Title 21 Code of Federal Regulations Part 58 establishes Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies supporting applications for research or marketing permits for FDA-regulated products. Covers organization, facilities, equipment, testing operations, records, and reporting requirements to ensure the quality and integrity of safety data. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does 21 CFR Part 58 — Good Laboratory Practice (GLP) have?

21 CFR Part 58 — Good Laboratory Practice (GLP) has 31 controls organised across 7 domains. The largest domains are Facilities (Subpart C) (6 controls), Equipment and Operations (Subparts D & E) (5 controls), Test Articles and Protocol (Subparts F & G) (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does 21 CFR Part 58 — Good Laboratory Practice (GLP) map to?

21 CFR Part 58 — Good Laboratory Practice (GLP) maps to 422 other compliance frameworks. The top mapping partners are NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements (13% coverage), NIS2 Directive Implementing Acts (13% coverage), UK Telecommunications (Security) Act 2021 (13% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with 21 CFR Part 58 — Good Laboratory Practice (GLP) compliance?

Start your 21 CFR Part 58 — Good Laboratory Practice (GLP) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about 21 CFR Part 58 — Good Laboratory Practice (GLP) 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 31 controls and track your progress.

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