Pharmaceutical Manufacturing, Audit-Ready by Design
A single Odoo app for batch traceability, QC and OOS gating, deviation and CAPA management, lot QA release with dual e-signatures, SOP and training enforcement, and vendor qualification — the complete 21 CFR Part 11 compliance backbone for pharma manufacturers.
The problem
Every batch must be traceable from raw material to dispatch, every deviation investigated and closed, and every operator action signed and time-stamped to satisfy FDA 21 CFR Part 11 and EU/WHO GMP rules. Most pharma manufacturers still run this on paper batch records, spreadsheet vendor lists, and binder-based training logs — and assemble five separate apps just to cover traceability, QC, CAPA, training, and vendor qualification.
The solution
Cerevantix Pharmaceutical GMP Manufacturing unites batch traceability, QC/OOS/deviation/CAPA gating, lot QA release with dual e-signatures, SOP and training enforcement, and vendor qualification in one Odoo app. Every gate blocks real production and dispatch, so compliance is enforced, not just recorded — one cockpit, one audit trail, one price.
Everything your QA team needs to pass an audit
Every capability below is implemented in the module.
Batch Traceability & Genealogy
Forward and backward lot-level lineage from raw material receipt through production, QC, and dispatch, with one-click drill-down to any related deviation.
QC Specs & Inspection Gating
Physical, chemical, and biological specifications with pass/fail inspections wired directly into work orders, blocking manufacturing order and dispatch until QC passes.
Out-of-Specification Investigation
Out-of-specification results auto-trigger a two-phase investigation — lab error versus process, material, or equipment — with documented root cause and disposition.
Deviation & CAPA Management
Immediate containment actions, 5-Whys root cause analysis, severity classification, and investigation deadlines, with CAPA traceable back to its originating deviation.
Lot QA Release & Dual E-Signature
Quarantine, Released, Rejected, and Hold lot gating with Four-Eyes Production Lead plus QA/QP e-signatures (SHA-256) required before stock becomes sellable.
21 CFR Part 11 Audit Trail & CoA
Read-only, time-stamped audit trail for every tracked field and signature, with auto-generated Certificates of Analysis on QA release.
Material Review Board
Kanban workflow auto-routes non-conforming batches through quarantine, committee review, dual sign-off, and signed disposition certificates.
SOP Lifecycle & Training Gating
Draft-to-effective SOP control auto-loaded at each routing step, with training expiry checks that block unqualified operators from being assigned.
Vendor Qualification & AVL
Token-based vendor portal, GMP questionnaire scoring, and automatic purchase order blocking for vendors not on the Approved Vendor List.
How it works
Qualify & Receive
Vendors are qualified through the AVL portal before a PO can be confirmed; incoming materials enter QC quarantine automatically on receipt.
Manufacture Under Control
Line clearance, SOP-linked routing steps, and training-gated operator sign-offs keep every batch record compliant as it happens.
Gate on Quality
QC inspections, OOS investigations, and deviations block manufacturing order completion and dispatch until every open issue is resolved.
Release with Confidence
Dual e-signatures release the lot, auto-generate the Certificate of Analysis, and leave a tamper-evident 21 CFR Part 11 audit trail.
Frequently asked
No sales fog. If your question isn't here, email us and we'll answer it the same way.
Yes. Every disposition decision and signature is captured in a read-only, time-stamped audit trail, and lot release uses dual Four-Eyes e-signatures with SHA-256 tamper detection to satisfy 21 CFR Part 11 and equivalent EU/WHO GMP expectations.
Buy it on the Odoo App Store
Purchase, download and install directly from the official Odoo Apps Store — you'll always get the latest supported build.
Pharmaceutical GMP Manufacturing
Batch genealogy, QC and OOS gating, deviation and CAPA, dual e-signature lot release and SOP training enforcement — with 21 CFR Part 11 audit trail and vendor qualification.
Buy on Odoo App Store