Batch record review software — built for review by exception.
V5 surfaces only what QA needs to see — missing signatures, out-of-spec readings, deviations, skipped steps — instead of forcing a page-by-page review of every batch. The clean batches release in minutes; the exceptions get the attention they deserve.
What breaks without this.
Page-by-page paper review burns QA hours
A 40-page batch record reviewed line by line costs 2–4 hours of senior QA time — every batch, every day.
Exceptions hide in the noise
When everything looks the same, the missing initials and the OOS reading slip through to release — and the FDA finds them.
Release backlogs delay shipment
Paper review queues build up over the weekend; product sits in quarantine costing working capital and customer service-levels.
Records-by-execution. Compliance, by design.
Exception-only review queue
V5 only puts a batch in front of QA when something needs attention: missing signature, OOS, deviation, skipped step, out-of-sequence event. Clean batches auto-route for release.
Side-by-side exception evidence
Each flagged item opens with the rule it broke, the evidence (scan, e-signature, sensor reading), and the linked deviation/CAPA in one pane.
E-signature release in two clicks
QA reviews the exception, applies the disposition, and Part 11-compliant e-signs the release — without leaving the screen.
Audit trail that survives inspection
Every review action — open, comment, accept, reject, escalate — is captured with user, time and reason in the immutable Part 11 trail.
Proof points
- Review-by-exception queue auto-built from MBR rules
- Part 11 e-signature on every disposition
- Linked deviation / CAPA / OOS records in one pane
- Typical QA release time drops from hours to minutes per batch
Built to satisfy
- 21 CFR 211.192 (Production record review)
- 21 CFR 211.188 (Batch production and control records)
- 21 CFR Part 11 / EU Annex 11
- EU GMP Chapter 4 (Documentation)
- ICH Q7 §6.7 (Batch production record review)
Related on V5
Frequently asked questions
What is review by exception?+
An FDA- and EMA-endorsed model where only batches with exceptions (missing data, OOS, deviation, skipped step) are routed for full QA review. Clean batches release automatically against pre-approved rules in the MBR.
Is review by exception compliant with 21 CFR 211.192?+
Yes — provided the exception-detection rules are documented in the validated MBR, the exception list is reviewed and signed by QA, and the audit trail captures every decision. V5 enforces all three.
How fast can we deploy?+
Most sites move from paper batch review to exception review in 7–14 days once the MBR is digitised.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.