1. Presentation

Advanced Pharmaceutical Laboratory Management turns Dolibarr ERP/CRM into a complete management platform for pharmaceutical laboratories, drug-manufacturing laboratories, food-supplement and cosmetic laboratories, biotech companies and pharmaceutical distributors.

The module covers the full operational, commercial, industrial, quality and regulatory scope of a modern laboratory while remaining fully integrated with native Dolibarr features. It is designed to support Good Manufacturing Practices (GMP/BPF) and ISO quality management principles.

Module identity

2. Architecture & workflow

The module is built on a generic, key-driven object engine. Each business object is described by a field specification that generates its SQL table, PHP class, list and card pages, and a shared registry. This keeps the code homogeneous, secure and easy to maintain.

Main business workflow

Product creation → Formulation → Raw-material supply → Production planning → Batch manufacturing → Quality control → Batch release → Storage → Distribution → Sales → Full traceability.

Business objects (17)

·       Pharmaceutical products (with AMM/marketing-authorization, therapeutic class, pharmaceutical form)

·       Raw materials (active ingredients, excipients, packaging) with certificate of analysis and quarantine

·       Formulations and formulation composition lines (versioned)

·       R&D projects

·       Production orders (manufacturing pipeline)

·       Batches / lots

·       Quality controls (analysis laboratory)

·       Suppliers (qualification)

·       Distribution shipments

·       Equipment and equipment maintenance

·       Regulatory & quality documents

·       Quality audits

·       Non-conformities

·       Corrective & preventive actions (CAPA)

·       Automatic alerts

3. Functionalities

Executive dashboard — A modern control center with five zones (production, quality, stock, commercial, regulatory), a manufacturing pipeline preview and analytical charts (monthly production, production by product, non-conformities by category, batch expiry).

Pharmaceutical products — Advanced product records with identification, regulatory data (AMM number, marketing country, regulatory status) and technical data (composition, dosage, packaging, shelf life, storage conditions).

Raw materials — Active ingredients, excipients and packaging with supplier, origin, certificate of analysis, supplier batch, expiry date and reception/control/quarantine/validation state.

Formulations — Versioned formulas linked to products, with a detailed composition (raw materials, quantities, percentages) and validation workflow.

R&D — Management of new-drug, generic, reformulation and food-supplement projects with phase, budget, cost and deadline tracking.

Production — Production orders with planned/produced quantities, production line and a Kanban manufacturing board across preparation, manufacturing, packaging, control and release stages.

Batch management — Complete lot lifecycle (manufacturing, quality control, validated, rejected, recall) with fabrication and expiry dates, operator and warehouse.

Traceability — Full upstream and downstream traceability: from a finished batch back to its raw materials and supplier lots, and forward to the delivered customers, including all quality controls.

Quality control — Physico-chemical, microbiological, stability and conformity controls with sample, method, specifications, result, analyst and biological validation.

Batch release — GMP release workflow where the quality manager releases or rejects batches based on their quality-control results.

Pharmaceutical stock (FEFO) — First-Expired-First-Out stock management of raw materials and finished products, with expiry badges and critical-stock alerts.

Suppliers & distribution — Supplier qualification (certifications, quality rating, audits) and distribution to distributors, pharmacies, hospitals and wholesalers.

Equipment maintenance — Production and laboratory equipment with preventive, corrective, calibration and qualification maintenance.

Regulatory documents — A quality document repository (SOP, certificates, technical sheets, reports, audits, validations) with version, approval and expiry management.

Non-conformities & CAPA — Deviation management and corrective/preventive actions with root cause, severity, responsible, due date and effectiveness.

Reporting — A reporting hub with production, yield, quality, non-conformity, CAPA, stock, expiry, regulatory and commercial reports, exportable to CSV, Excel and PDF.

Automatic alerts — A daily alert engine for batch expiry, low stock, document expiry, overdue controls, planned maintenance and overdue CAPA.

4. Permissions & user profiles

Permissions are grouped by domain. Read and write are granted by default on activation so the module is immediately usable; delete and administration are granted explicitly.

5. Native Dolibarr integration

·       Third parties: raw-material suppliers, customers, distributors, pharmacies, partners.

·       Products: pharmaceutical products extend the native product catalogue.

·       Stock: stock movements, batches and warehouses.

·       Purchases: supplier orders, receptions and supplier invoices.

·       Sales: quotes, customer orders, invoices and payments.

·       Projects: R&D and product-development projects.

·       ECM/DMS: quality documents, certificates and regulatory files.

6. Demonstration data

On first activation the module generates a complete, realistic demonstration dataset (pharmaceutical products, raw materials, formulations, R&D projects, production orders, batches, quality controls, suppliers, distributions, equipment, maintenance, documents, audits, non-conformities, CAPA and native customers, products and invoices). Two buttons on the configuration page let administrators regenerate or remove this dataset; removal only affects records flagged as demonstration data.