Regulatory Coverage Hub
Affinity QMS is built to support compliance across every major FDA regulatory framework, international standard, and industry certification that matters to regulated companies in the US and globally. Browse every framework below, organized by category.
How to Use This Hub
Each page below covers one regulatory framework in depth: what it requires, who must comply, how Affinity QMS maps to its requirements module by module, and answers to the most common compliance questions. Use the category sections to navigate by your industry. If you serve multiple regulated markets, the cross-vertical pages will show you how one Affinity QMS account can address multiple frameworks simultaneously.
21 CFR Part 820
The legacy FDA QSR for medical device manufacturers. Covers design controls, document control, CAPA, production controls, and corrective action systems for FDA-registered device facilities.
↗FDA QMSR 2026
The 2024 rule aligning FDA device regulation with ISO 13485. Replaces 21 CFR Part 820 with an ISO-harmonized QMS framework. Effective February 2026.
↗ISO 13485:2016
The international QMS standard for medical device manufacturers. Required for CE marking in Europe, Health Canada licensing, TGA approval in Australia, and MDSAP participation.
↗MDSAP
A single audit that satisfies regulatory requirements for FDA (US), Health Canada, TGA (Australia), ANVISA (Brazil), and PMDA (Japan) simultaneously. Required for Canadian medical device market access.
21 CFR Part 111
FDA's current Good Manufacturing Practice regulation for dietary supplement manufacturers. Governs production, packaging, labeling, batch records, testing, and quality control for all dietary supplement facilities.
↗21 CFR Part 211
The FDA cGMP regulation for OTC drug and pharmaceutical manufacturers. Covers quality control, production controls, laboratory controls, validation, and distribution record requirements.
↗USP Standards
United States Pharmacopeia standards for pharmaceutical and supplement manufacturers. Key chapters include USP <797> (sterile compounding), USP <800> (hazardous drugs), and compendial test methods referenced by FDA regulations.
↗NSF / Third-Party
NSF International certification including NSF/ANSI 173 (dietary supplements), NSF Certified for Sport (sport nutrition), and NSF food safety programs. Required by premium retailers and professional sports organizations.
↗PCAB / ACHC
Pharmacy Compounding Accreditation Board accreditation for sterile and non-sterile compounding pharmacies and 503B outsourcing facilities. Increasingly required by hospital and health system purchasing programs.
21 CFR Part 117
The FDA cGMP baseline for all registered food manufacturing facilities under FSMA. Covers sanitation, employee practices, facility design, equipment maintenance, and production controls.
↗FSMA / HARPC
The preventive controls framework under FSMA requiring a written Food Safety Plan with hazard analysis, preventive controls, monitoring, corrective actions, and verification activities — managed by a PCQI.
↗GFSI / SQF
Safe Quality Food Program — the most commonly required food safety certification in US retail. Three levels (SQF 1, 2, 3) with annual recertification audits. Grade AA required by premium retail buyers.
↗GFSI / BRCGS
Brand Reputation Compliance Global Standards — required by UK and European retailers. Issue 9 covers food safety culture, VACCP, environmental monitoring, and supplier controls. Grade AA achievable through unannounced audit.
↗GFSI / FSSC
Food Safety System Certification built on ISO 22000 plus sector-specific PRPs and FSSC additional requirements. Version 6 (2023). Preferred by global food manufacturers and companies already operating within an ISO management system framework.
↗NSF Food Safety
NSF International's GFSI-recognized food safety auditing and certification program for food manufacturers and processors. Accepted by major foodservice and retail buyers as a GFSI-benchmarked compliance standard.
ISO/IEC 17025:2017
The international standard for laboratory competence. Covers both management system requirements and technical competence requirements for testing and calibration labs. Required for ILAC MRA-recognized accreditation worldwide.
↗A2LA
American Association for Laboratory Accreditation — the largest US ISO 17025 accreditation body. ILAC signatory. Covers application, on-site assessment, corrective action, surveillance, and biennial reassessment processes.
Not sure which regulatory frameworks apply to your industry? Start with your vertical — each page maps every applicable regulation and certification to a single Affinity QMS account configuration.
Affinity QMS is the only QMS built to adapt across all six regulated verticals and every major compliance framework — without forcing you to choose between regulatory rigor and operational simplicity.
Book a Demo