LAB SYSTEMSINDEX

Map the system. Preserve the evidence. Test the handoff.

Authority library

Regulation and standards record

Each record preserves the issuing authority, jurisdiction, instrument or authority type, legal or operating status, version and application dates, affected audience, workflow mapping, source link, and interpretation boundary.

FDA-regulated electronic records and signatures within the rule's scope · U.S. federal regulation

21 CFR Part 11

Part 11 sets criteria under which FDA considers electronic records and signatures trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.

Current codified regulationU.S. Food and Drug Administration

Laboratory records supporting drug CGMP operations within scope · U.S. federal drug CGMP regulation

21 CFR 211.194

The section specifies content for laboratory records, including samples, methods, test data, calculations, results, initials, dates, second-person review, and investigation references.

Current codified regulationU.S. Food and Drug Administration

Nonclinical laboratory studies within FDA GLP scope · U.S. federal regulation

21 CFR Part 58

Part 58 establishes organizational, personnel, facility, equipment, protocol, operating-procedure, record, reporting, and archive requirements for specified nonclinical studies.

Current codified regulationU.S. Food and Drug Administration

Organizations determining Part 11 scope and enforcement approach · U.S. regulatory guidance

FDA Part 11 Scope Guidance

The guidance explains FDA's narrow interpretation of Part 11 scope and enforcement discretion for certain provisions while retaining applicable predicate-rule requirements.

Final guidanceU.S. Food and Drug Administration

Drug CGMP data and records within scope · U.S. regulatory guidance

FDA Data Integrity Guidance

The guidance addresses complete, consistent, accurate data; metadata; audit trails; access; review; blank forms; testing into compliance; and investigation of data-integrity problems.

Final guidanceU.S. Food and Drug Administration

Medical-device production and quality-system software within the guidance's scope · U.S. regulatory guidance

FDA Computer Software Assurance Guidance

The guidance describes a risk-based approach to establishing confidence in automation used for production or quality systems, including intended use, risk analysis, assurance activities, records, and appropriate testing.

Final guidanceU.S. Food and Drug Administration

Computerised systems used in EU GMP-regulated activities · EU GMP guideline

EU GMP Annex 11

Annex 11 addresses risk management, personnel, suppliers, validation, data, accuracy checks, storage, printouts, audit trails, change, security, incident management, signatures, business continuity, and archiving.

Published Annex 11; revision activity must be monitoredEuropean Commission

Documentation in EU GMP operations · EU GMP guideline

EU GMP Chapter 4

Chapter 4 places specifications, instructions, procedures, records, reports, controls, approval, availability, legibility, traceability, correction, retention, and hybrid-system relationships within the pharmaceutical quality system.

Published guidelineEuropean Commission

GxP data and records within MHRA scope · UK regulatory guidance

MHRA Data Integrity Guidance

The MHRA record addresses data governance, lifecycle, criticality, metadata, audit trails, access, review, retention, hybrid systems, and organizational culture.

Published guidance with MHRA notice about later OECD advisory guidanceUK Medicines and Healthcare products Regulatory Agency

GMP and GDP data governance within participating inspectorate contexts · Inspectorate guidance

PIC/S PI 041-1

PI 041-1 describes data governance, risk, lifecycle, organizational controls, computerized and paper systems, audit trails, review, outsourcing, and remediation considerations.

Final guidancePharmaceutical Inspection Co-operation Scheme

Nonclinical health and environmental safety studies accepted under participating programs · Intergovernmental GLP principles

OECD GLP Principles

OECD GLP principles organize test-facility management, quality assurance, facilities, apparatus, test systems, materials, procedures, study performance, reporting, and archives.

Active principles and compliance-monitoring programOrganisation for Economic Co-operation and Development

Data integrity in GLP studies and facilities · Intergovernmental advisory document

OECD GLP Advisory Document No. 22

The advisory document addresses data governance, lifecycle, criticality, metadata, computerized systems, dynamic data, cloud and service arrangements, review, archive, and reconstruction in GLP settings.

Published advisory documentOrganisation for Economic Co-operation and Development

Testing and calibration laboratories using the standard · International conformity-assessment standard

ISO/IEC 17025:2017

ISO/IEC 17025 specifies requirements for laboratory competence, impartiality, and consistent operation across resources, processes, and management systems.

Published international standardInternational Organization for Standardization

Medical laboratories using the standard · International medical-laboratory standard

ISO 15189:2022

ISO 15189 specifies quality and competence requirements for medical laboratories, including governance, resources, pre-examination, examination, post-examination, information, risk, and improvement.

Published international standardInternational Organization for Standardization

Organizations implementing a quality management system · International management-system standard

ISO 9001:2015

ISO 9001 specifies requirements for a quality management system covering context, leadership, planning, support, operation, performance evaluation, and improvement.

Published edition with a revised edition under developmentInternational Organization for Standardization

Research-data stakeholders across organizations and disciplines · U.S. federal research-data framework

NIST RDaF 2.0

RDaF organizes research-data concerns across planning, lifecycle, infrastructure, standards, governance, workforce, and community perspectives.

Published frameworkU.S. National Institute of Standards and Technology

Scientific and analytical data interoperability · Industry technical framework

Allotrope Framework

The Allotrope Framework combines a data format, data models, and taxonomies or ontologies intended to improve laboratory-data standardization and interoperability.

Active technical framework and documentationAllotrope Foundation

Laboratory device and service interoperability · Industry technical standard

SiLA 2

SiLA 2 defines service-oriented communication concepts for integrating laboratory devices and software, including feature definitions and a communication protocol.

Active standard and implementation ecosystemSiLA Consortium

Analytical measurement data and metadata interchange · Open analytical-data standard project

AnIML

AnIML defines an XML-based approach for representing analytical measurement data, metadata, techniques, and experiment context.

Active community standard projectAnIML community project

NIH-funded research subject to the policy · U.S. federal research-funding policy

NIH DMS Policy

The policy requires applicable researchers to plan for management and sharing of scientific data and to comply with approved plans, subject to limitations and protections.

Active policyU.S. National Institutes of Health

How to read the library

Binding requirements, official guidance, technical standards, implementation guides, program rules, and authority data are not interchangeable. Each page names the source class and states what it can and cannot establish about an organization or product.