Odoo Powered Pharmaceutical ERP for Manufacturing Quality

Pharmaceutical ERP software for GMP manufacturers, holding every quality decision in one place. Real time visibility, enforced approvals, and audit ready records all on a single Odoo ERP platform built for regulated batch manufacturing.

Odoo Modules for Pharma
  • PharmaERP Core
  • CAPA & Deviations
  • Traceability & CoA
  • SOP & Training
  • Vendor Qualification
Quality Cockpit
Live · Batch Release
Open QC Tests
18orders
6 incoming · 9 IPQC
Quarantine Queue
7lots
2 past target dwell
Open Deviations
4records
1 critical
Open CAPA
5actions
3 verified this week
Training Compliance92%
QUARANTINE APPROVED ON HOLD REJECTED RELEASED RECALLED
5
Integrated Modules
6
Quality Domains
Live
Batch Release Control
1
Connected Platform

Pharma ERP built on three connected control layerss

Pharmaceutical manufacturing runs across incoming material control, in-process production, and GMP batch release each layer producing specification, quality, and 21 CFR Part 11 records that must stay linked across teams, sites, and inspectors.

Pharma records, unified

Most manufacturers still run on spreadsheets, a separate QMS, and paper batch records reconciling signatures by hand while batches wait on the floor and audit risk grows. PharmaERP unifies materials, specifications, BMRs, deviations, CAPA and QA release inside Odoo ERP, so every GMP decision is written against the records your teams already use.

  • Material approved vendor list, quarantine, storage class, expiry and retest.
  • Method QC specifications, master formula, IPQC controls.
  • People SOP versions, training records, role-gated approvals.
  • Governance deviations, CAPA, OOS and OOT, audit trail.
  • Release QA disposition, certificate of analysis, lot genealogy.
Inbound

Vendor Qualification

Inbound

Quarantine Receipt

Quality

Incoming QC

Production

Master Formula

Production

Batch Record

Production

In Process Control

Governance

OOS & Deviation

Governance

CAPA

People

SOP & Training

Release

QA Release & CoA

Six ERP pillars purpose built for pharmaceutical GMP

Each pillar maps to a control a GMP inspector will ask about configured, integrated and supported by Cybrosys, an official Odoo Partner.

01

Quality Control

QC specifications, test orders and result lines unified into one GMP quality record.

  • Incoming, IPQC & finished specs
  • Spec versioning & approval
  • Analyst entry, reviewer sign-off
  • Automatic pass/fail verdicts
02

Batch Manufacturing

Master formula control and electronic batch records in one auditable BMR workflow.

  • Versioned master formula
  • BMR step execution
  • In process control results
  • Theoretical vs actual yield
03

Deviations & CAPA

Classified GMP deviations driving corrective and preventive action to closure.

  • Critical / major / minor
  • Five root cause categories
  • Corrective & preventive types
  • Release / reject disposition
04

Traceability & Release

Lot genealogy, certificate of analysis and QA disposition in one audit ready release desk.

  • Upward & downward genealogy
  • CoA built from real results
  • QA release queue
  • Field level audit trail
05

SOP & Training

Controlled SOPs connected natively to GMP operations who is trained, on which version.

  • Draft → Review → Effective
  • SOPs on BoM operations
  • Assessment scoring
  • Nightly expiry cron
06

Vendor & Supply

Questionnaires, approved vendor list and purchase approval gates in one system.

  • Portal questionnaires
  • Weighted audit scoring
  • Approved Vendor List
  • QA gate on purchase orders

The open source ERP advantage for GMP manufacturers

Odoo's modular architecture and open source licensing make it a proven backbone for pharmaceutical ERP software affordable, customizable and supported by an official Odoo Partner.

Open Source Flexibility

Own the LGPL-3 source code. Customize specifications, yield reconciliation, deviation workflows and approval rules without licensing lock in. No vendor black boxes, and nothing hidden from a CSV reviewer.

Integrated Management

One shared data backbone across materials, master formulas, BMRs, quality, training and finance removing the overnight interface that reconciles a standalone QMS against your ERP.

Flexible Implementation

Deploy by site, by product family or by module. Start with QC specifications and batch records, then add CAPA, traceability, training or vendor qualification without re-platforming.

Efficient Procurement

Vendor questionnaires, weighted audit scoring, an approved vendor list and a QA gate on the purchase order all natively linked to products, lots and QC specifications.

Enforced Segregation of Duties

Four roles under one privilege model, with QA deliberately held out of create and delete rights. Data entry and approval sit with different people, enforced by the system and not by policy.

Centralised Data Access

Role based dashboards give real time visibility to operators, QC analysts, QA managers and directors all from one login, all reading the same GMP records an inspector would read.

Quality Core & Governance · Modules 01-03

Specifications, Batch Records & Investigations

From incoming material specifications and master formula control to batch execution, IPQC checks, deviations and corrective actions the quality core of PharmaERP unifies method, material and evidence records into one GMP record set.

Core Icon01

PharmaERP Core

Core

Foundation layer for shared configuration, role based security, the quality cockpit and every GMP record in the suite QC specifications, test orders, batch records and investigations.

  • Shared configuration & menus
  • Role based security groups
  • Central quality dashboard
  • QC specs, BMR, IPQC, OOS
CoreDashboardSecurity
Quality Icon02

CAPA & Deviations

Governance

Log a GMP deviation where it happened, classify severity and root cause, then drive corrective and preventive action through to verified closure.

  • Critical / major / minor classification
  • Five-category root cause analysis
  • Manufacturing, QC or packaging stage
  • Release / reject disposition
DeviationCAPARoot cause
Traceability Icon03

Traceability, CoA & Audit Trail

Release

Lot genealogy in both directions, a certificate of analysis built from QC results, a QA release queue, and an ALCOA+ field level record of every change.

  • Upward & downward lot genealogy
  • CoA locked once released
  • QA release queue with disposition
  • Old value, new value, user, timestamp
CoAGenealogyAudit trail
People & Supply · Modules 04-05

Trained Operators & Qualified Suppliers

A batch is only as compliant as the operator who ran it and the material it was made from. These two ERP modules control who is trained to run a GMP operation, and which qualified vendors you may buy a regulated material from.

SOP Icon04

SOP & Training

Workforce Compliance

Version controlled standard operating procedures linked to the operations they govern, with training records that decide who may execute them.

  • Draft → Under Review → Effective → Archived
  • SOPs filtered onto BoM operations
  • Scored against an 80% default pass mark
  • Nightly cron expires lapsed training
SOPTrainingHR
Vendor Icon05

Vendor Qualification

Approved Vendor Control

Qualify suppliers with a scored questionnaire they answer on a portal, maintain the approved vendor list, and stop unapproved sourcing at the purchase order.

  • Questionnaire templates & weighting
  • Vendor portal with email invitation
  • Approval threshold, 70% by default
  • AVL enforcement on purchase orders
AVLPortalPurchase
+

Built to be Extended

Your Requirement

Serialisation, environmental monitoring, stability studies, or equipment qualification the suite is designed so a sixth tier drops in the same way the first five did.

  • Shared groups & permission helper
  • Menus graft onto the core app
  • Installed from Settings, not the code
  • LGPL-3, Odoo 19.0
CustomCybrosys
Release Control · Module 03

Batch Release Control inside Odoo

Very few pharmaceutical ERP platforms put the release decision in the same system as the stock. PharmaERP holds the QA release queue natively in Odoo, so open deviations, unfinished checks, and untrained operators block a release the moment they appear rather than at month end.

QA Release Queue ↔ Odoo
Monitoring · 18 open checks
Awaiting Release
6BMR
Blocking Deviations
1critical
Finished Goods QC
3orders
Certificates Issued
42CoA

Explore PharmaERP End to End

A guided look at the pharma ERP screens your teams use daily from QC specifications to batch records, investigations, training and vendor checks.

pharmaceuticalerp / overview / dashboard
PharmaERP quality overview dashboard showing open OOS, CAPA, deviations, QC tests, the weekly QC schedule and recent batches.
pharmaceuticalerp / quality control / qc test orders
QC test order under investigation with material details, specification, analyst sign-off and test result lines flagged out of specification.
manufacturing / batch records / bmr
Batch manufacturing record in progress showing batch identity, expected versus actual yield, and execution steps with operator and supervisor sign-off.
pharmaceuticalerp / quality control / oos investigations
Phase I out of specification investigation carrying the trigger test order, defected product, lot and the expected versus actual result.
pharmaceuticalerp / certificates of analysis
Certificate of analysis for a released batch listing production batch, lot, release date and every QC test result behind the release.
pharmaceuticalerp / operations / sop
Effective standard operating procedure showing SOP code, version, work centre, approver, effective date and assigned employees.
apps / pharma
Odoo Apps list filtered to the five PharmaERP modules: core, CAPA and deviations, SOP and training, traceability and CoA, and vendor qualification.

Unified quality command centre

One real time cockpit across open QC tests, the quarantine queue, deviations, and CAPA counts by stage keep every team working from the same quality picture.

Live KPIsQuarantineDeviationsRole based views

Specifications & test orders

Versioned specifications per product and stage, expanded into test orders where the analyst enters results and a reviewer signs them off against computed limits.

SpecsTest ordersPharmacopoeiaVerdicts

Batch manufacturing records

Follow a batch through draft, in progress, on hold, and completed with signed execution steps, in process results, and theoretical against actual yield reconciled before closure.

BMRIPQCMaster formulaYield

OOS, deviations & CAPA

A failing result opens a two phase investigation laboratory review first, then manufacturing carrying the expected limits and actual value across, and escalating into deviations and CAPA.

Phase I / IIRoot causeCAPADisposition

Genealogy, CoA & audit trail

Trace a finished goods batch to every input lot, or a raw material lot forward to every batch it entered then issue the certificate of analysis and read the audit trail.

GenealogyCoAAudit trailRecall

SOP & training records

Procedures move draft to effective to archived, attach to the BoM operations they govern, and carry per-employee assessment scores that expire on a nightly cron.

SOPVersionsScoresExpiry

Start with what you need, scale as you grow

One application plus four optional tiers from quality control and batch records to CAPA, traceability, training, and vendor qualification installed and connected inside one Odoo backend.

5 appsModularConnectedOdoo-native

Launch PharmaERP across your plant in 4 steps

A practical ERP rollout path built around your product families, QC specs, approval hierarchy and the regulator you answer to.

01

Scope Products & Modules

Define your rollout scope across product families, material types, specifications, storage categories, deviation categories, approval hierarchy, and which compliance tiers you need.

02

Configure Quality Workflows

Configure roles, sequences, QC specifications, master formulas, SOPs, BoM operations, vendor questionnaires, putaway rules, and the vendor and training thresholds.

03

Validate Batch Scenarios

Run real cycles end to end from quarantined receipt and incoming QC to batch execution, a deliberate deviation, OOS investigation, QA release, and certificate of analysis.

04

Launch & Expand

Go live by line or by site, track adoption through the quality cockpit, then scale across product families, additional plants, and the remaining compliance tiers.

Bring your quality workflows
Onto one connected platform.

Request a PharmaERP walkthrough around your operations, modules, product families, approvals and compliance reporting. Our team configures a tailored ERP demo within 48 hours.

Common questions & answers

Answers to the most common questions about pharmaceutical ERP modules, deployment, validation, and support for regulated manufacturing.

What is pharmaceutical ERP software and what does it do?

Pharmaceutical ERP software is an integrated platform built specifically for regulated manufacturing. It unifies operations across incoming material control, in process production, and final batch release managing specifications, batch records, deviations, investigations, training, and audit trails within a single connected system.

What is the difference between a generic ERP and a pharmaceutical ERP?

A generic ERP manages finance, stock, and orders but has no concept of a quarantined lot, a specification limit, an out of specification investigation, or a qualified person releasing a batch. Pharmaceutical ERP software is purpose built for GMP operations and regulatory compliance.

For small and mid size manufacturers, platforms like SAP or Oracle are expensive and still require heavy customisation. PharmaERP, built on Odoo by Cybrosys, covers these gaps without the enterprise price tag.

Does PharmaERP support electronic batch manufacturing records?

Yes. Each manufacturing order carries a batch manufacturing record moving through draft, in progress, on hold, and completed. Execution steps follow the routing operations, in process results are captured in line with the signer and timestamp, and theoretical against actual yield is reconciled before the batch can close.

The bill of materials is treated as a master formula record versioned, approved by a named person, and carrying a theoretical yield and change reference so a batch always points at a specific approved revision.

How many user roles are there and how is approval separated?

Four roles are assignable User, QA, Manager, and Administrator presented as one selection on the user form under a single Odoo 19 privilege. The notable design choice is that QA does not inherit User: a QA user reads everything and approves or rejects submitted records and can edit fields, but cannot create or delete them. Data entry stays with the User role.

Behind those four sit ten groups you never assign by hand six escalating technical groups, three feature groups that unlock the optional tiers, and one administrator bundle. Every workflow button checks the caller's group through a shared permission helper.

What happens when a test result fails?

A failed test order can move to under investigation and open an out of specification investigation, carrying the expected minimum, expected maximum, actual value, and unit across automatically. Phase I reviews the laboratory event and records whether an assignable laboratory error was found; where none is, Phase II widens into the batch record, materials, and equipment.

The investigation closes with a named investigator, a written conclusion, and a release or reject disposition and the affected lot is segregated into the configured Rejected location.

Can it manage cold chain and controlled storage?

The product carries an Odoo Storage Category plus a free-text storage conditions note, and putaway routes each move line into a matching warehouse sub-area. Turning on the Enforce Storage Class company setting makes transfer validation check the destination, so a move that would land a classified material somewhere unsuitable is refused rather than logged.

Can PharmaERP manage a product recall?

Yes. Recalled is one of six lot statuses, and batch genealogy traverses in both directions from a suspect raw material lot down to every finished batch it entered, and from a finished pack back up to every input. That is the query a recall depends on, and it runs against live data rather than an archived report.

Do we have to install all five modules?

No. PharmaERP is the only application; CAPA and Deviations, Traceability and CoA, SOP and Training, and Vendor Qualification are optional tiers, each installable from a checkbox in Settings. The traceability tier requires the CAPA tier because certificates and genealogy surface deviation relations directly the CAPA tier itself installs on its own.

Is the system validated for regulated use?

No software product arrives validated validation is something you perform on your installation, in your environment, against your own intended use. What PharmaERP provides is the technical foundation that makes it feasible: readable source code, versioned modules, a field level audit trail, enforced state transitions, and role based segregation of duties.

Whether your installation satisfies 21 CFR Part 11, EU GMP Annex 11, WHO GMP, or your national authority depends on how it is configured, validated, and operated. Cybrosys can support that exercise alongside your QA function, but the protocols, the testing, and the sign-off remain yours.

Is PharmaERP available for Odoo Enterprise and Community editions?

Cybrosys delivers PharmaERP on both Odoo Community and Odoo Enterprise. The suite targets Odoo 19.0 under LGPL-3 and builds on standard applications Manufacturing, Inventory, Purchase, Accounting, Employees, Website, and Product Expiry. Enterprise deployments add Odoo's hosted infrastructure, Studio, and official support alongside Cybrosys's customisation and implementation services.

Ready to Modernise Pharma Quality & Manufacturing Operations?

Speak with our pharmaceutical ERP specialists and discover how PharmaERP can streamline your Quality Control, Batch Manufacturing, CAPA, Traceability, and Vendor Qualification operations.