eBR software that turns paper batch records into a 30-day project, not a 3-year programme.
Electronic batch records that an FDA inspector reads end-to-end. Bound e-signatures, hash-chained audit trail, live deviation workflow, and the rest of MES on the same platform. Most plants run their first signed batch within 30 days.
You're shopping for eBR because paper has stopped scaling.
QA review takes 5–10 days per batch and the backlog never shrinks
Last inspection cited contemporaneity or audit-trail depth
Operators transcribe from clipboard to system — and you know what that means at release
Deviations get caught at end-of-batch, never at the failing step
Your ERP module 'does eBR' but QA won't sign on it
Your eBR vendor wants 18 months and seven figures before go-live
Electronic batch records that don't fight the inspector.
Bound e-signatures
Every signature cryptographically bound to the record under 21 CFR Part 11. Cannot be lifted onto another batch.
Hash-chained audit trail
Every action, every record, append-only. Inspectors verify end-to-end that nothing was edited or backdated. ALCOA+ by construction.
eBR + eDHR on one engine
Pharma batch records and medical-device history records on the same platform. One configuration, one audit, one training footprint.
Live deviation workflow
Out-of-tolerance, missed sequence, expired material — opens at the failing step, pages QA, blocks the next step.
ERP + LIMS connected
NetSuite, SAP, Dynamics, QuickBooks Enterprise, LabWare, STARLIMS. Signed REST + webhooks, idempotency-safe.
Live in weeks
Pre-configured for regulated batch manufacturing. Most plants run their first signed batch within 30 days.
eBR savings come from structure, not from killing the printer.
- Cuts batch-record review time by 60–80%
- Eliminates the 'review by exception' bottleneck that holds batches in QA for days
- Replaces 40+ paper SOPs with one configured execution model
- FDA inspection-ready audit response in hours, not weeks
- GAMP 5 Second Edition with CSA-aligned test evidence at onboarding
Designed against the inspector's checklist.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
eBR software, answered.
What is eBR software?
eBR (electronic batch record) software replaces paper batch records with a 21 CFR Part 11–compliant electronic system that captures each manufacturing step contemporaneously. Operators execute on a kiosk, signatures are bound, deviations open at the failing step, and the released batch record is generated automatically with a full audit trail.
eBR vs MBR — what's the difference?
MBR (master batch record) is the approved template — the recipe, instructions, and specifications. eBR (electronic batch record) is the executed record of an actual batch made from that template. The MBR is controlled under document control; the eBR is captured under MES execution.
Is V5's eBR compliant with 21 CFR Part 11 and EU GMP Annex 11?
Yes — natively. Bound e-signatures, hash-chained audit trail, RBAC with author-cannot-self-approve, authority checks, validation evidence delivered at onboarding under GAMP 5 Second Edition.
How does eBR differ from MES?
eBR is one capability of a modern MES. A full MES adds work-order dispatch, real-time OEE, equipment status, calibration tracking, and ERP integration. V5 delivers both — eBR / eDHR alongside the MES execution layer — on the same platform.
How long does eBR implementation take?
Most plants run their first signed batch within 30 days of kickoff. Full multi-line rollouts typically take 8–16 weeks depending on integration complexity.
Run your first signed batch in 30 days.
Free trial. Real eBR module. No sales gate.