Authority 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 QMSR
The QMSR amends FDA's device current good manufacturing practice requirements in 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, while retaining FDA-specific statutory and regulatory requirements. FDA began using a new device inspection process when the rule became effective.
FDA 21 CFR Part 11
Part 11 defines criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
FDA drug CGMP
Parts 210 and 211 establish current good manufacturing practice requirements for drug manufacture, processing, packing, and holding, including organization, facilities, equipment, components, production controls, laboratory controls, records, reports, returned products, and complaints.
ISO 13485:2016
ISO 13485 specifies quality-management-system requirements for organizations involved in one or more stages of the medical-device lifecycle and emphasizes regulatory requirements, risk-based processes, supplier control, documentation, and product realization.
ICH Q10
ICH Q10 describes a pharmaceutical quality-system model across development and commercial manufacturing, including management responsibilities, process and product monitoring, CAPA, change management, management review, knowledge management, and quality risk management.
ICH Q9(R1)
ICH Q9(R1) provides principles and examples for systematic quality risk management across the pharmaceutical product lifecycle and addresses formality, risk-based decision-making, subjectivity, product availability, and managing risk through assessment, control, communication, and review.
EU GMP Chapter 4
Chapter 4 describes expectations for the generation, control, review, approval, distribution, maintenance, and retention of GMP documentation and records, including paper, electronic, photographic, and other media.
EU GMP Annex 11
Annex 11 applies GMP principles to computerized systems and addresses lifecycle risk management, personnel, suppliers, validation, data, accuracy checks, storage, printouts, audit trails, change control, incident management, periodic evaluation, security, signatures, continuity, and archiving.
EU MDR
The MDR establishes rules for placing medical devices on the EU market and covers economic operators, conformity assessment, quality systems, clinical evidence, technical documentation, UDI, registration, vigilance, post-market surveillance, and market surveillance.
EU IVDR
The IVDR establishes rules for in vitro diagnostic devices, including classification, conformity assessment, quality systems, performance evidence, technical documentation, UDI, registration, vigilance, post-market surveillance, and performance studies.
eCTD v4.0
eCTD v4.0 defines a harmonised structure and exchange model for regulatory submissions, with regional controlled vocabularies, module-one requirements, validation criteria, transmission specifications, and implementation timelines maintained by authorities.
ISO IDMP
The ISO IDMP family standardizes the identification and description of substances, dose forms and routes, units of measurement, regulated pharmaceutical products, and regulated medicinal products. EMA is implementing these concepts through substance, product, organization, and referential master-data services.
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.