GMP Deviation, Change Control & Batch Release
GMP deviation and change control workflows with e-signature gated batch release
GMP Deviation, Change Control & Batch Release Deviation handling, change control with impact assessment and approval routing, batch quality-review checklists and QP-style batch disposition (hold / release / reject) gated behind a completed quality review and an accountable electronic release signature, with a full audit trail.
Key Features
Batch Quality Review
Batch Quality Review. Tracks Reference, Product, Batch Number, Manufacturing Date, Reviewer. One-click start review, complete review, reset.
Batch Release Disposition
Batch Release Disposition. Tracks Reference, Product, Batch Number, Batch Size, Unit. One-click submit for review, place on hold, remove hold, reject, release.
GMP Change Control
GMP Change Control. Tracks Reference, Title, Description, Reason for Change, Initiated By. One-click submit impact review, submit for approval, approve, reject, start implementation.
GMP Deviation
GMP Deviation. Tracks Reference, Title, Description, Date Reported, Reported By. One-click start investigation, submit impact assessment, request capa, submit for approval, approve.
Batch Quality Review Checklist Template Item
Batch Quality Review Checklist Template Item. Tracks Checklist Item, Sequence, Mandatory, Active.
Batch Release Electronic Signature
Batch Release Electronic Signature. Tracks Batch Release, Ready for Release, Block Reason, Signing As, Type the confirmation statement. One-click confirm release.
Use Cases
Screenshots
Audit Log
Batch Quality Reviews
Batch Releases
Sign Release Batch
Change Controls
Deviations
Specifications
- Compatible: Odoo 18.0 / 19.0
- License: OPL-1
- Languages: 35+
- Author: Pokutsoft
- Dependencies: base, mail
- Support: support@pokutsoft.com
- Update date: 2026-07-24