An eBMR that an FDA investigator could sign off on, every batch.
Built for 21 CFR 210/211 and ICH Q7 cGMP.
← 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.
- › 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 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.
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.
Ask anything · No credit card · Onboard in days, not months