Electronic batch record software, built for the inspector, not the slide deck.
V5 Ultimate is the electronic batch record system regulated manufacturers run when paper has stopped scaling and the next FDA or notified-body inspection is closer than the last. Signed eBR / eDHR from the kiosk. Hash-chained audit trail. Live deviation workflow. 21 CFR Part 11 and EU GMP Annex 11 native. Most plants run their first signed batch within 30 days.
You're shopping for electronic batch record software because paper has stopped working.
QA review takes 5–10 days per batch and the backlog never shrinks
Last inspection cited contemporaneity, attributability, 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
Spreadsheets, paper, three half-built apps, one $4M validation invoice last year
Electronic batch record software that an FDA inspector will read end-to-end without an Excel reconciliation.
Bound e-signatures under 21 CFR Part 11
Every step that requires a signature gets one — author, reviewer, approver — cryptographically bound to the record so the signature cannot be lifted onto another batch.
Hash-chained, append-only audit trail
Every action on every record is hash-chained. Inspectors can verify end-to-end that no row was edited or backdated after the fact. ALCOA+ by construction.
eBR and eDHR in one platform
Pharma batch records and medical-device history records run on the same execution engine. One configuration, one audit, one training footprint.
Live deviation workflow
An out-of-tolerance weighing, a missed sequence, an expired material — the deviation opens at the failing step, pages QA, and blocks the next step until disposition.
Connected to your ERP and LIMS
Signed REST + webhooks with idempotency keys. NetSuite, SAP, Dynamics, QuickBooks Enterprise, LabWare, STARLIMS — the integration scoping is hours, not months.
Live in weeks, not quarters
Pre-configured for regulated batch manufacturing. Most plants run their first signed batch within 30 days of kickoff. No multi-year implementation programme.
The savings come from structure, not from killing the printer.
- Cuts batch-record review time by 60–80% — the record is right at release, not after re-work
- 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 — every event is queryable
- Validated against GAMP 5 Second Edition with CSA-aligned test evidence
Designed against the inspector's checklist, not the vendor's slide.
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 (§8), 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 as a six-month after-the-fact project.
Electronic batch record software, answered.
What is electronic batch record software?
Electronic batch record (eBR) software replaces paper batch records with a 21 CFR Part 11–compliant electronic system that captures each manufacturing step as it happens. Operators execute the recipe on a kiosk, signatures are bound to the record, deviations open at the failing step, and the released batch record is generated automatically with a full audit trail.
Is V5 Ultimate compliant with 21 CFR Part 11 and EU GMP Annex 11?
Yes. V5 ships with native Part 11 and Annex 11 controls — bound e-signatures, RBAC that enforces author-cannot-self-approve, hash-chained audit trail, operational system checks, and authority checks. Validation evidence is delivered as part of onboarding under GAMP 5 Second Edition with CSA-aligned test approach.
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 Ultimate delivers both — eBR / eDHR alongside the MES execution layer — on the same platform.
How long does 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 and the number of products.
Can V5 integrate with our existing ERP?
Yes. V5 integrates with NetSuite, SAP, Microsoft Dynamics 365, QuickBooks Enterprise, Sage X3, Infor, and others through signed REST + webhooks with idempotency keys built in. The seven MES-vs-ERP boundary decisions are pre-resolved in the V5 configuration so scoping is fast.
See V5's electronic batch record software run a real batch.
Free trial. No "talk to sales" gate. First signed batch in 30 days.