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 workflows you'd expect to see on day one.
Not a generic feature list — these are the specific vet pharma workflows V5 ships configured for, ready to run on your batches.
API + excipient dispensing
Two-person weigh-out, scale verification, and lot tie-back to every batch.
Compounding & fill control
Recipe rev, addition order, temp profile, and fill weights captured live.
QC assay + impurity testing
Assay, impurities, and microbial results bundled with two-sig release.
Species + withdrawal-period labeling
Target species, withdrawal days (meat / milk / eggs), and Rx text rendered per SKU.
eBMR with QP / RP release
Preparer, reviewer, and authorized-person signatures — VICH / EU 2019/6 ready.
Pharmacovigilance intake
Adverse events tied to lot, species, region, and reporter — FDA CVM / VMD package on demand.
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.
Paste your stack. See what V5 replaces vs keeps.
ERP, LIMS, MES, paper logs, spreadsheets — list what you run today and our AI returns an honest side-by-side: what V5 absorbs, what stays, and the realistic integration + retraining windows for Vet Pharma.
Paste your current setup. See what V5 replaces — and what stays.
Honest side-by-side for veterinary pharmaceuticals operations. No form, no signup. Ask V5 names what V5 swaps out, what should stay, and what the switching risks actually are.
Be specific — naming the actual tools gets a sharper comparison.
What does V5 look like for your vet pharma operation?
Tell us your scale and current stack. Get modules, rollout, compliance fit, and pricing band — pre-seeded for your industry.
Plain-English playbooks for Vet Pharma regulations.
Structure, recurring inspection findings, and a practical 60-day path — written for QA, regulatory and operations leads.
Plain-English guide to FDA 21 CFR Part 11 — electronic records, electronic signatures, audit trails, and a practical path to a Part 11-compliant eQMS without theatre.
Plain-English guide to the Drug Supply Chain Security Act (DSCSA) — serialization, aggregation, EPCIS exchange, verification, and the path through enhanced drug distribution security.
Plain-English guide to EU Good Distribution Practice (2013/C 343/01) — Responsible Person duties, temperature control, qualifications, falsified medicines, and inspection.
A practical, audit-ready walkthrough of EU GMP Annex 11 — what each clause means, what inspectors look for, and how to evidence compliance for any GxP system.
Plain-English guide to GAMP 5 second edition and FDA's Computer Software Assurance — software categories, risk-based testing, intended use, and a leaner validation pack.
Plain-English guide to the ISPE GAMP Records & Data Integrity (RDI) Good Practice Guide — ALCOA+, data lifecycle, hybrid records, audit trail review, and a defensible RDI programme aligned with MHRA, FDA, WHO and PIC/S expectations.
Plain-English guide to ICH Q10 — the global Pharmaceutical Quality System. Management responsibilities, lifecycle stages, enablers, and a practical implementation path.
Plain-English guide to ICH Q8(R2), Q11 and Q12 — QbD, design space, control strategy, Established Conditions and PACMPs. The QbD-to-lifecycle toolkit FDA, EMA and PMDA expect.
Plain-English guide to Regulation (EU) 2024/1689 — risk tiers, high-risk AI obligations, GMLP, PCCPs, and how the AI Act stacks on Annex 11, 21 CFR Part 11, GAMP 5, CSA and ICH Q9.
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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