Dietary supplements software with 21 CFR 111 evidenced per batch — MMR-locked, BPR-live, identity-tested.
Dietary supplements cGMP under 21 CFR Part 111 — Master Manufacturing Records (MMR), Batch Production Records (BPR), 100% component identity testing, specifications for finished product, and holds until QA release — all evidenced as live workflow. Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
You're shopping because the last FDA inspection wrote you up on identity testing and MMR-to-BPR traceability.
Master Manufacturing Records live in Word — no version lock, no signature
Batch Production Records reconstruct the MMR from paper travelers
Component identity testing (§111.75) is a lab log, not a release gate
Finished-product specifications aren't enforced before QA release
Held product releases before all specs are met
Complaint records don't tie back to the batch or component lot
21 CFR 111, subpart by subpart.
Master Manufacturing Record
Approved MMR per product — bill of materials, in-process specs, equipment, sampling plan, packaging & labeling. Locked, versioned, signed under Part 11.
Batch Production Record
BPR self-builds from the MMR at execution. No reconstruction, no re-typing — the BPR IS the record of what happened, signed at each step.
Component identity testing
§111.75(a) — 100% identity testing of every incoming component lot, with method, spec, result, analyst, review. No release without pass.
Finished-product specs + release
§111.75(d) — finished product held until all identity, purity, strength, composition and contaminant specs are met. Release is signed, timestamped, evidenced.
Complaints + returns (Subpart O)
Written procedure, complaint file, QA review, investigation and reportable-event tracking tied to batch and component lot.
Personnel + training (Subpart B)
Qualification records, training matrix, hygiene practices — the evidence 483s reach for first.
What changes when 21 CFR 111 is one live system.
- MMR-to-BPR reconciliation is instant — the BPR was built from the MMR
- Identity testing is a release gate the software enforces, not a lab log
- Held product cannot be released with an open OOS or missing spec
- Complaint-to-batch trace is one click, not a two-day file pull
- FDA 483 findings on documentation drop to near zero
- Same platform serves NSF / cGMP for Sport, USP verification and export dossiers
Every subpart FDA will read.
21 CFR 111 Subparts A–P
Personnel, physical plant, equipment, production and process controls, quality control, MMR & BPR, laboratory, manufacturing, packaging & labeling, holding & distribution, returned dietary supplements, complaints, records.
DSHEA + FTC Act
Structure/function claim substantiation records, NDI notifications (where applicable), and label / promotional claim linkage kept as reviewable evidence.
21 CFR Part 11
Bound e-signatures, hash-chained audit trail, and controlled printouts — the audit-trail engine FDA expects behind every signed MMR / BPR.
NSF / cGMP + USP verification (optional)
Third-party cGMP certifications (NSF/ANSI 173 registration, NSF Certified for Sport, USP dietary supplement verification) supported by the same evidence base.
Dietary supplements software, answered.
What is dietary supplements software?
Dietary supplements software is the cGMP platform that runs a supplement contract manufacturer or brand owner's operation under 21 CFR Part 111 — Master Manufacturing Records, Batch Production Records, component identity testing, finished-product specifications, holds and release, complaints, and returns — with live evidence FDA inspectors accept. It replaces the paper traveler / Word MMR combination most facilities inherit.
Does V5 enforce 100% component identity testing?
Yes. §111.75(a) requires identity testing on every component lot before use. In V5 the identity test is a release gate on the incoming lot — the lot cannot be issued to a batch without a passed identity result signed by a qualified analyst. It's not a lab log to hope inspectors don't read.
How does the MMR-to-BPR relationship work?
One MMR per product, versioned and signed. When a batch is scheduled, the BPR is generated from the current effective MMR — same BOM, same in-process specs, same sampling plan. Deviations from the MMR are captured against a specific MMR revision, not against an abstract 'the record'.
Does V5 support contract manufacturing for multiple brand owners?
Yes. Brand-owner segregation (formulas, specs, labels, batch records, complaints) is native. A contract manufacturer can hold dozens of brand owners on one platform without cross-visibility.
How is finished-product release enforced?
§111.75(d) requires that the finished dietary supplement meet all product specifications for identity, purity, strength, composition and contaminants before release. V5 holds the lot until every required spec has a passed result and a QA signature — the system will not print release documentation with an open OOS.
How long does implementation take?
Most supplement facilities reach a 21 CFR 111-ready state within 10–14 weeks — MMRs approved, BPR templates configured, identity testing wired to receiving, spec-based release enforced, complaints and returns live. Migration from paper travelers typically shortens the next FDA inspection prep from weeks to days.
Stop surviving 483s. Run 21 CFR 111 the way FDA reads it.
Free trial. Real MMR-to-BPR evidence. No sales gate.