21 CFR 211 batch records for animal-health drugs — FDA CVM ready.
Built for 21 CFR 210/211, FDA CVM oversight, ICH Q7, EU Annex 11, and PIC/S GMP.
← 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.
- › API lot
- › scale
- › spec
- › operator
- › recipe rev
- › addition order
- › temp
- › operator
- › fill weight
- › tare
- › container
- › operator
- › assay
- › impurities
- › spec
- › QA sig
- › species
- › withdrawal d
- › Rx text
- › lot
- › preparer
- › reviewer
- › release
- › ship
- 07:00·step 01MMR review
Approved MMR is snapshotted into the WO at release. Two e-sigs (preparer + reviewer) required before any operator can start.
21 CFR 514 / 211.186 - 07:30·step 02Dispense
API + excipients dispensed against the WO. Scale streams live; every weighment captured to the BMR.
- 10:00·step 03Compound + fill
Recipe addition order enforced. Temperatures, mix times, fill weights stream from equipment — no clipboard.
- 12:00·step 04QC assay
Sample pulled. Assay + impurity results signed. OOS → CAPA opens automatically and the WO holds.
VICH GL - 14:00·step 05Withdrawal label
Label prints with species, withdrawal period, Rx text, lot — pulled from the registered product record. Cannot be over-typed.
21 CFR 514 - 16:00·step 06BMR review + release
QA reviews the assembled BMR. Two e-sigs close the batch. PDF locks. Same record FDA CVM gets if they walk in tomorrow.
The terms your auditor uses
- FDA CVM
- FDA Center for Veterinary Medicine — US regulator for animal drugs.
- VICH GL
- International veterinary medicinal product harmonisation guidelines.
- Withdrawal period
- Days between last dose and slaughter / milking — required on every food-animal product label.
- MMR / BMR
- Master + Batch Manufacturing Records — same controls as human pharma under 21 CFR 211.
- VMD
- Veterinary Medicines Directorate — UK regulator equivalent to FDA CVM.
- OOS
- Out of Specification — triggers an investigation and holds the WO.
Sound familiar? We built this for you.
BMR is a paper exercise; reviewer sign-off lags release by days.
Cold-chain excursions are tracked in a separate logger — not linked to the batch.
Annex 11 / Part 11 e-sig discipline isn't enforced on every critical step.
Deviations and CAPAs sit in a QMS that doesn't talk to the BMR.
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.
Snapshot-from-MMR BMR
Two-person e-sig (211.186 / 211.188) — reviewer sees an exact reproduction of the approved MMR.
Cold-chain on the batch
Excursion events bound to the released batch and visible on the QA release screen.
Part 11 / Annex 11 e-sigs
Identity-verified e-sig with reason + audit trail on every critical action.
Deviation → CAPA in-line
QMS events fired by execution events, not retyped into a separate system.
Spin up a workspace seeded for Vet Pharma.
Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.
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