21 CFR Part 111 compliance, NPA GMP certification, and FDA inspection readiness — built for supplement manufacturers who need a QMS that scales from startup to commercial production.
21 CFR Part 111 software · Supplement GMP compliance · Dietary supplement QMS · NSF certification ready · From $499/mo
FDA's 21 CFR Part 111 sets strict cGMP requirements for dietary supplement manufacturers — covering everything from master manufacturing records and batch production records to supplier qualification and label claim substantiation. FDA inspections are increasing. Affinity QMS gives supplement companies the documented infrastructure to pass.
Physical Plant & Grounds / Personnel
Documentation for personnel qualifications, hygiene programs, and training records are maintained in Affinity QMS and linked directly to your SOPs — so every employee qualification is traceable to the procedure they are authorized to perform.
Components, Packaging & Label Operations
Identity testing requirements for every component, supplier qualification, and incoming material inspection are managed in the Supplier Management module. COAs are linked to batch records so the chain of custody is unambiguous at inspection.
Production & Process Controls
Master manufacturing records, batch production records, in-process controls, and finished product testing documentation are all managed in Affinity QMS. When an FDA investigator asks for a batch record, it is complete, signed, and retrievable in under 60 seconds.
Holding & Distribution / Returned Products / Product Complaints
Complaint management workflows, deviation tracking for returned products, and distribution records are linked to your finished product specifications — giving you a full product lifecycle record that satisfies FDA's traceability requirements end-to-end.
Activate the modules you need for 21 CFR Part 111 compliance. Add certification-specific modules as you pursue NSF, USP, or Informed Sport.
Supplier Management — Built for 30+ Ingredient Suppliers
The average supplement brand manages COAs and qualification records for 20–50 raw material suppliers. Affinity QMS's Supplier Management module maintains your approved vendor list (AVL), qualification status, incoming inspection records, and COA history — all searchable and retrievable when FDA asks. Learn more about Supplier Management →
FDA Inspection Readiness
21 CFR Part 111 requires documented procedures, records, and controls. Companies that build the QMS after the inspection notice don't have time to fix it. Affinity QMS keeps every document, batch record, and CAPA linked and retrievable before any inspection date is set.
Master Manufacturing & Batch Production Records
MMRs and BPRs must be complete, accurate, and retained for every lot. Manual systems create gaps that show up as 483 observations. Affinity QMS structures MMR and BPR creation, in-process capture, deviation linking, and batch release into a single traceable workflow.
Supplier Qualification at Scale
Managing approved supplier lists, certificates of analysis, and incoming material specs across dozens of ingredient vendors requires a system, not a spreadsheet. Affinity QMS maintains your AVL, tracks COAs, and links supplier qualification records to every batch.
NPA GMP / NSF Certification Preparation
Third-party GMP certifications require documented evidence across every Part 111 subpart. Auditors look for systems, not binders. Affinity QMS pre-maps your quality documentation to NPA GMP, NSF/ANSI 173, and Informed Sport requirements so your audit readiness is continuous.
Affinity QMS is built to grow alongside your certification roadmap — from FDA cGMP compliance through every major voluntary certification program supplement brands and retailers require. View full 21 CFR Part 111 coverage →
A modern alternative to legacy supplement compliance platforms — modular pricing, no setup fees, and workflows that adapt to your production process.
Legacy supplement compliance software forces you to adapt your process to the software. Affinity QMS is built the other way around — modular pricing means you activate what you need now and expand as you grow, with no setup fees and no enterprise contract. The moment your company builds an in-house testing lab that needs ISO 17025 accreditation, or expands into OTC drug cGMP, Affinity QMS scales with you — without a second subscription or a second validation package.
See how Affinity QMS gives dietary supplement manufacturers the documented, audit-ready quality system they need for FDA inspections, NPA GMP certification, and NSF/ANSI 173 — without legacy software pricing.