Pass a 111 audit on any random batch, any random day.
Built for 21 CFR 111, FSMA, and NSF/USP certification audits.
← Different industryThe codes you're accountable to — at the data layer.
Five steps from receive to release — with the regulator on the hook at the end.
Tap to expand · download as PNG · paste into an audit prep deck.
From login to release — no end-of-shift paperwork.
- › lot
- › supplier
- › CoA
- › quarantine
- › NIR / FTIR id
- › specs met
- › QC sig
- › release
- › BPR step
- › weights
- › order
- › operator
- › fill weight
- › AQL
- › operator
- › time
- › count
- › torque
- › label rev
- › lot
- › MMR signed
- › BPR closed
- › CoA out
- › ship lot
- 07:00·step 01Identity test
Incoming raw material gets FTIR / HPLC identity test before release. Result attached to the lot — no test, no use.
21 CFR 111.75 - 07:30·step 02MMR snapshot
WO release snapshots the approved MMR into the batch — exact weights, in-process specs, and the master label all locked.
- 09:00·step 03Dispense + blend
Scale streams every weighment. Blender RPM + time captured automatically. Yield calculated live, variance flagged.
- 12:00·step 04Encapsulation / tableting
Press writes capsule weight checks every 15 min. Out-of-band readings hold the line and open a deviation.
- 14:30·step 05QC release
Finished lot tested against the MMR spec. Label content checked against the formula, ingredient by ingredient.
21 CFR 111.70 - 16:00·step 06BPR sign-off
Two e-sigs close the Batch Production Record — preparer + independent reviewer. CoA renders from the same snapshot.
21 CFR 111.205
The terms your auditor uses
- MMR
- Master Manufacturing Record — the approved, immutable recipe per 21 CFR 111.205.
- BPR
- Batch Production Record — the signed reproduction of the MMR for a specific batch (111.255).
- Identity test
- Required test on every incoming dietary ingredient before use (111.75).
- DSHEA
- Dietary Supplement Health and Education Act — defines what counts as a supplement.
- Structure/function claim
- Permitted claim about how an ingredient affects body structure — not a disease claim.
- NSF / cGMP audit
- Third-party audit against 21 CFR 111 — most retailers require one before they'll list you.
Sound familiar? We built this for you.
MMR approval, identity testing, and quality release all live in different binders.
Inbound ingredient identity testing isn't tied to release — material gets used before QA signs off.
Label claims drift from the formula; the marketing label and the BPR don't match.
Co-mans get the blame at audit because the trail of who-did-what isn't clean.
The record assembles itself as the work happens.
No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.
MMR + BPR by construction
Approved MMR snapshots into the work order. The executed work order IS the BPR.
Identity testing gates release
Ingredient identity (visual, FTIR, HPLC) is a signed gate — material can't be dispensed without it.
Label-to-formula reconciliation
Per-serving claims auto-calculate from the released formula; label printed from the same source.
Quality holds are physical
Quarantine status enforces at scan time. Operators can't pick what QA hasn't released.
Spin up a workspace seeded for Dietary Supplements.
Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.
Ask anything · No credit card · Onboard in days, not months