An eBMR that an FDA investigator could sign off on, every batch.
Built for 21 CFR 210/211 and ICH Q7 cGMP.
The 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.
- › material
- › lot
- › weight
- › two e-sigs
- › BMR step
- › params
- › operator
- › time
- › tablet wt
- › hardness
- › in-process QC
- › operator
- › film weight
- › spray rate
- › exhaust temp
- › operator
- › assay
- › dissolution
- › QP / RP sig
- › CoA
- › GTIN
- › serial
- › lot / expiry
- › agg parent
- 07:00·step 01Shift handover
Production lead reviews open work orders. The MMR for today's batch is already snapshotted into the WO — no Word doc to chase.
21 CFR 211.188 - 07:30·step 02Dispense
Operator scans the WO at the weigh booth. V5 prints the picklist, the scale streams live, every weighment is captured to the BMR.
21 CFR 211.101 - 09:00·step 03Granulation
Step won't unlock until dispense is signed and within tolerance. Process parameters (temp, mix time) stream from the granulator to the record.
- 11:00·step 04In-process check
QC pulls a sample, logs the result, signs. If OOS → CAPA opens automatically and the WO holds.
21 CFR 211.110 - 13:30·step 05Compression + coating
Tablet press and coater write yield, defects, and PAT readings to the BMR. Scrap weighed and reconciled live.
- 16:00·step 06QC release
QA reviews the assembled BMR — every step typed, hashed, signed. Two e-sigs (preparer + reviewer) close the batch.
21 CFR 211.186 - 16:30·step 07BMR archived
PDF rendered from the snapshot. Immutable. Same record an FDA investigator gets if they walk in tomorrow.
The terms your auditor uses
- MMR
- Master Manufacturing Record — the approved, immutable recipe (21 CFR 211.186).
- BMR
- Batch Manufacturing Record — the live, signed reproduction of the MMR for a specific batch (211.188).
- API
- Active Pharmaceutical Ingredient — the molecule that does the work.
- OOS
- Out of Specification — a result outside acceptance criteria. Triggers an investigation.
- ALCOA+
- Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available).
- PAT
- Process Analytical Technology — real-time process measurement instead of end-batch testing.
Sound familiar? We built this for you.
Master Batch Records live in Word; production records live on paper; reconciliation takes weeks.
Single-signature formula approvals fail 211.186 the moment they're audited.
Lot recall takes days — there's no forward genealogy from API lot to finished bottle.
Investigators flag 'data integrity' findings on every audit.
The workflows you'd expect to see on day one.
Not a generic feature list — these are the specific pharmaceutical workflows V5 ships configured for, ready to run on your batches.
Master Batch Record library
Approved MBRs are immutable; every work order snapshots from an approved master rev.
Two-person dispense weighing
Preparer + independent reviewer e-sigs on every API and excipient weigh-out, per 211.186 / 211.188.
In-process QC + deviation capture
Tablet weight, hardness, dissolution checks captured live; out-of-spec = automatic deviation + hold.
DSCSA / FMD serialization & aggregation
GTIN + serial + lot + expiry encoded and aggregated parent-to-child for full pack hierarchy.
Forward / backward genealogy
API lot → bulk → bottle, in seconds. Recall scope in one query.
ALCOA+ data integrity
Every record attributable, contemporaneous, original — full audit trail with reason-for-change.
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.
Immutable MBR, live BMR
Approved master records snapshot into every work order. The batch record is the master — executed and signed live.
Two-signature approvals
Preparer + independent reviewer e-sigs on every approved formula, per 211.186 / 111.205.
Forward & backward genealogy
From API CoA to finished pack, in seconds. Recall scope in one query.
ALCOA+ data integrity
Every record is attributable, legible, contemporaneous, original, accurate — and complete, consistent, enduring, available.
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 Pharmaceutical.
Paste your current setup. See what V5 replaces — and what stays.
Honest side-by-side for pharmaceutical 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 pharmaceutical 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 Pharmaceutical regulations.
Structure, recurring inspection findings, and a practical 60-day path — written for QA, regulatory and operations leads.
Plain-English guide to 21 CFR Part 211 — current Good Manufacturing Practice for finished pharmaceuticals. Subparts B through K, data integrity, ALCOA+, and an FDA inspection-ready path.
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 Regulation (EU) 2024/1689 — risk tiers, high-risk AI obligations, GMLP, Predetermined Change Control Plans (PCCPs), and how the AI Act stacks on Annex 11, 21 CFR Part 11, GAMP 5, CSA and ICH Q9.
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 the EU Falsified Medicines Directive 2011/62/EU and Delegated Regulation 2016/161 — unique identifier, tamper-evident features, EMVS connection and the path to clean dispense-time verification.
Plain-English guide to EU Good Distribution Practice (2013/C 343/01) — Responsible Person duties, temperature control, qualifications, falsified medicines, and inspection.
Plain-English guide to the 2022 revision of EU GMP Annex 1 — sterile medicinal products. Contamination Control Strategy, QRM, grade A/B/C/D, barrier technology and aseptic process simulation.
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.
Spin up a workspace seeded for Pharmaceutical.
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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