Pharmaceutical ERP on Odoo 19
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5 integrated modules — from vendor qualification to Certificate of Analysis — enforced approvals and audit-ready records in place of shared drives, paper batch records and spreadsheets.
Quality Command Core
QC specifications, test orders and Batch Manufacturing Records, with in-process quality checks (IPQC) and out-of-specification (OOS/OOT) investigations built in.
Deviations & CAPA
Log a deviation the moment something unexpected happens, classify its severity, run root cause analysis, and drive it through Corrective and Preventive Actions to verified closure.
Traceability & Release
Generate a Certificate of Analysis and trace batch genealogy in both directions, all backed by an ALCOA+ compliant, field-level audit trail.
SOP & Training
Version-controlled Standard Operating Procedures (Draft → Review → Effective → Archived), linked to Bill of Materials operations, with training compliance tracked to expiry.
Vendor Qualification
Qualify vendors through weighted questionnaire scoring and enforce your Approved Vendor List directly on purchase orders — no unapproved supplier slips through.
One record set, from receiving dock to release desk
Pharmaceutical manufacturing runs across incoming material control, in-process production and GMP batch release — each stage producing specification, quality and audit-trail records that have to stay linked across teams, sites and inspectors. Most manufacturers still run that on spreadsheets, a standalone QMS and paper batch records, reconciling signatures by hand while finished batches wait on the floor and audit risk grows. The five modules below unify materials, specifications, BMRs, deviations, CAPA and QA release inside one Odoo database, so every GMP decision is written against the same records your teams already use.
Every GMP record, one shared configuration
The core module underneath the other four — shared configuration and menus, role-based security, and the quality cockpit every other capability reports into.
Shared Configuration & Menus
One set of configuration, menus and reference data every other module in the suite builds on.
Role-Based Security Groups
Four assignable roles — User, QA, Manager, Administrator — layered under escalating technical groups and the feature groups that unlock each optional tier.
Central Quality Cockpit
Open QC tests, the quarantine queue, deviations and CAPA counts rolled into one live dashboard, filtered by role.
QC Specs, BMR & Investigations
Specifications, Batch Manufacturing Records, in-process quality checks and out-of-specification investigations, all in one record set.
A deviation raised is a deviation tracked to closure
Nothing gets logged and forgotten — every deviation is classified, root-caused and driven through corrective or preventive action before it can close.
Severity Classification
Every deviation is logged critical, major or minor the moment it is raised, tagged to the manufacturing, QC or packaging stage it happened at.
Root Cause Analysis
A structured set of root-cause categories drives the investigation toward a corrective or preventive action, not just a closed ticket.
Corrective & Preventive Actions
CAPAs are typed, tracked and verified independently of the deviation that raised them, before either record can close.
Release / Reject Disposition
Every closed deviation carries an explicit release-or-reject call, tied back to the affected lot.
Genealogy and CoA, generated from real results
Traceability that runs in both directions, and a Certificate of Analysis that comes straight from recorded QC data — not a spreadsheet assembled after the fact.
Upward & Downward Genealogy
Trace a finished batch back to every input lot, or a raw-material lot forward to every batch it entered — in either direction, on live data.
Certificate of Analysis
Generated straight from recorded QC results and locked the moment a batch is released — never typed up by hand after the fact.
QA Release Queue
A dedicated release desk where QA gives, or refuses, the final disposition on a completed batch.
Field-Level Audit Trail
Old value, new value, user and timestamp captured on every change — ALCOA+-aligned throughout, not just at sign-off.
A batch that isn't ready doesn't get released
The QA release queue lives natively in the same database as the stock it is releasing, so an open deviation, an unfinished check or an untrained operator blocks a release the moment it appears — not at month end, when it's too late to matter.
Only a trained operator can run the operation
Standard Operating Procedures are version-controlled and linked directly to the Bill of Materials operations they govern, with per-employee training records that decide who is actually allowed to execute them.
SOP Lifecycle
Draft → Under Review → Effective → Archived, so only the current, approved version of a procedure is ever live.
Linked to BoM Operations
Procedures are filtered directly onto the Bill of Materials operations they govern, not filed away in a separate binder.
Assessment Scoring
Training is scored against a default 80% pass mark before a record counts as complete.
Nightly Expiry Cron
Lapsed training is expired automatically every night, so a stale certificate never quietly stays "valid".
Buy only from a supplier who has earned it
Every vendor is scored on a weighted questionnaire before it can reach the Approved Vendor List — and the purchase order itself is the gate that keeps an unqualified supplier out.
Scored Questionnaires
Weighted questionnaire templates score every supplier against the criteria your quality function actually cares about.
Vendor Portal
Suppliers answer their qualification questionnaire on an emailed portal link — no PDF forms round-tripped by email.
Approval Threshold
A configurable pass mark, 70% by default, decides whether a vendor earns a place on the Approved Vendor List.
AVL Enforcement
Purchase orders are gated against the Approved Vendor List, so an unqualified supplier can’t be bought from by accident.
Three workflows, fully connected
Procurement
Manufacturing
Quality Disposition
Every step is covered by role-based access (User, QA, Manager, Administrator) and an immutable, field-level audit trail — nothing is edited without a record of who changed what, and when.
What a live quality dashboard shows
Open checks, training compliance, active CAPAs and approved-vendor coverage, rolled up in one place instead of chased across spreadsheets.
Built to be owned, not rented
Open source, no lock-in
Own the source. Adjust CAPA severity rules, training pass marks or AVL scoring directly — nothing sits behind a vendor black box.
One data backbone
Quality, procurement, manufacturing and training share the same records, instead of a standalone QMS reconciled against the ERP overnight.
Roll out at your pace
Adopt by site or by product family — start with vendor qualification or deviations, then bring in the rest of the suite later.
Efficient procurement
Vendor questionnaires, weighted scoring, the Approved Vendor List and a QA gate on the purchase order — linked natively to products, lots and QC specifications, not bolted on as a side system.
Enforced segregation of duties
Four roles sit under one privilege model, with QA deliberately held out of create and delete rights — data entry and approval stay with different people, enforced by the system rather than by policy.
Centralised data access
Role-based dashboards give operators, QC analysts, QA managers and directors real-time visibility from one login, all reading the same GMP records an inspector would read.