Batch record software that releases product in hours — not next week.
V5 Ultimate electronic batch records replace paper BMRs and DHRs for US pharma, biotech, food and cosmetics manufacturers. Recipe-driven, review-by-exception, equipment-integrated and Part-11 signed — one shift ends, the next shift's release paperwork is already done.
You need batch record software because paper is costing you release days.
QA reviews every page of every batch — even the 95% with no exceptions
Handwritten weights and temperatures are transcribed twice and still wrong
Recipe changes ripple through paper masters that nobody re-controls
Reconciliation of materials, yields and losses happens after release, not during
Deviations captured on paper get lost between the floor and QA
A batch record can't be found six months later without an archive request
The eBR capabilities that actually shorten release.
Recipe → master → executed
Master batch record built from the recipe, executed batch record instantiated per lot — no re-typing, no version drift.
Live equipment integration
Weights, temperatures, torques, pH captured live from OPC-UA / MQTT / instrument APIs — no manual entry, no transcription errors.
Review by exception
QA reviews only the deviations, missed steps and out-of-range values — the compliant 95% is auto-approved with signature evidence.
Materials & yield reconciliation
Consumption, yield, loss and reconciliation computed in real time — release paperwork ready when the batch is.
In-line deviation capture
Deviations opened from the operator's execution screen, linked to the exact step, and routed to QA before the batch closes.
Part 11 signature stack
Bound signatures under §11.50/§11.70, hash-chained audit trail, printed-copy criteria — every executed record is inspection-ready.
What batch release looks like when the record works for you.
- Release cycle from 5–7 days to under 48 hours
- QA review time reduced 60–80% via review by exception
- Recipe change re-controls across master and future executed records in one action
- Zero-finding Part 11 audits on batch records and audit trail
- Executed batch record retrievable in seconds — years later — with signed audit trail intact
The regulations your batch record is measured against.
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.
Batch record software, answered.
Is a BMR, BPR, MBR and eBR the same thing?
Loosely. Master Batch Record (MBR) is the template; Batch Manufacturing Record (BMR) or Batch Production Record (BPR) is the executed instance; electronic Batch Record (eBR) is the digital form of either. V5 uses the recipe → master → executed model with an audit-trail-backed link between them.
Do we need MES for eBR, or is it a QMS module?
V5 delivers eBR as part of MES, but on the same platform as QMS, LIMS and WMS. That means deviations, CAPAs, sampling and warehouse movements all reference the same batch — no integration seams.
Can we integrate equipment we already have?
Yes. Standard connectors for OPC-UA, MQTT, Modbus, HL7, and instrument-specific APIs (Mettler, Sartorius, HPLC). Legacy equipment without a network can use handheld barcode capture with signed operator entry.
What is review by exception, really?
QA reviews only the steps flagged by rules — out-of-range readings, skipped steps, deviations, unauthorized overrides. The compliant remainder is signed automatically with full audit-trail evidence — accepted by FDA and MHRA when properly configured.
How does V5 handle recipe change control?
Recipe changes route through change control with impact assessment, retest scope, and controlled re-release of the master record. Future executed batches inherit the new master; in-flight batches finish under the version they started.
See an eBR executed on your own recipe — release in one shift.
Free trial. Recipe → master → executed → release, on one platform.