Release by exception, with nothing hidden.
QA opens a batch record that has already been checked, sees only what needs attention, and releases with an electronic signature. The full record and audit trail stay one click away for anyone who needs to look deeper.
Captured in the record
- Release checklist results
- Reviewer actions on each exception
- Release or rejection signature with meaning
- Linked QC and deviation records
- Time from batch end to release
- Exported dossier with checksum
Release · Batch 2611
Released- Batch recordComplete · 412 entries
- AI review highlights2 resolved · 0 open
- DeviationsDEV-2026-0381 · closed
- QC resultsCertificate of analysis · pass
- Review time1 day (paper: 6 days)
- Released byQA Head · e-signed
How it flows
- 1
Ready
The record arrives with AI review attached.
- 2
Review
QA works through exceptions.
- 3
Release
Authorised QA signs the release.
- 4
Archive
The record is locked and archived.
What your team works with every day.
Review by exception
QA sees the exceptions first: highlights, deviations, corrections and out-of-trend values. Clean steps can be reviewed in bulk.
Release checklist
Record complete, deviations closed, QC results passed, labels reconciled. Release is blocked until each item is met.
Electronic release
Authorised QA staff release with an electronic signature that records name, date, time and the meaning of release.
Full audit trail
Every entry, correction, signature and review action is kept with who, what, when and why.
Batch dossier export
Export the complete executed record as a signed PDF for customers, auditors or regulatory submissions.
Long-term archive
Released records are archived read-only for the retention period your markets require.
GMP and responsible AI
The rules we hold ourselves to, written into how the product works.
- 01
Only authorised QA personnel review and release batches. The AI highlights issues but never approves or releases anything.
- 02
Records follow data-integrity principles: attributable, legible, contemporaneous, original and accurate, with complete audit trails and electronic signatures.
- 03
Validation for regulated use is done together with you, under your quality system.
- 04
The platform supports, but does not replace, your regulatory responsibilities as the manufacturer.
- 05
Batch data is encrypted, backed up and never sold.
About QA Release
Who can release a batch?
Only users your QA has given the release role. Role assignments are themselves logged and reviewed.
Is it designed for 21 CFR Part 11 and EU Annex 11?
It is built around audit trails, access control and electronic signatures that these rules expect. Validation is done with your team under your quality system.
Your next batch could leave the cleanroom like 2611.
Tell us about your products and lines. We will walk your QA and production heads through one of your own batch records, step by step.
- Record
- Your plant · first production line
- Meaning
- Approved for a live walkthrough
- Signed by
- You, in under two minutes