Validated Odoo ERP for Pharma Formulations, Medical Devices & Healthcare

We customize and validate Odoo to strictly comply with FDA 21 CFR Part 11 and EU GMP Annex 11 standards. This includes configuring immutable audit trails that log every database write/edit with user ID, timestamp, and previous/new values; dual-authentication electronic signatures (Approver and Reviewer/Witness) for critical manufacturing step sign-offs, recipe approvals, and batch release; role-based access security; automated password expiration; and comprehensive Computer System Validation (CSV) documentation (IQ/OQ/PQ protocols).

Odoo provides end-to-end forward and backward lot genealogy. From Active Pharmaceutical Ingredient (API) raw materials to excipients, intermediate blends, and finished packaged goods, every batch retains a unique lot number. Odoo's inventory engine enforces First-Expired, First-Out (FEFO) picking logic to prevent expired stock from being dispatched. In the event of a quality audit or market recall, Odoo generates a 360-degree traceability report in under 30 seconds.

Yes. Leveraging HashStudioz's proprietary IoT hardware expertise, we integrate Odoo with BLE, LoRaWAN, and 4G Modbus temperature/humidity data loggers installed in cold-storage warehouses, cleanrooms, and refrigerated transit vehicles. Odoo records real-time environmental telemetry, triggers automated SMS/email deviation alerts if thresholds are breached, and attaches temperature excursion logs directly to batch release records.

Odoo automates Quality Control Points across raw material receiving, in-process blend sampling, and pre-release finished good inspections. Incoming shipments are placed in an automated quarantine state until analytical laboratory tests (assay, dissolution, purity, microbial limits) pass. Once validated, Odoo automatically generates a digitally signed, tamper-proof Certificate of Analysis (CoA) PDF.

Yes. Odoo supports Medical Device Manufacturing (ISO 13485 compliance) with unique Device Master Records (DMR), Device History Records (DHR), Non-Conformance and Corrective and Preventive Action (CAPA) tracking, and Unique Device Identification (UDI / GS1 Datamatrix barcode) serialization on packaging labels.

Odoo MRP digitizes Master Formula Records (MFR) and dynamic multi-level Bills of Materials (BOM) with strict versioning and Engineering Change Orders (ECO). Machine operators on the cleanroom floor utilize touch-screen tablets for Electronic Batch Manufacturing Records (eBMR / eBPR), recording step-by-step raw material weighing, line clearances, yield percentages, and supervisor digital sign-offs.

Yes. For wholesale drug distributors, Odoo supports Drug Supply Chain Security Act (DSCSA) compliance in the United States, EU Falsified Medicines Directive (FMD), and national serial verification systems. It captures serialized 2D GS1 barcodes at unit, bundle, case, and pallet levels to ensure chain of custody verification.

Yes. We engineer secure HL7, FHIR, and RESTful API gateways connecting Odoo with Hospital Information Systems (HIS), Laboratory Information Management Systems (LIMS), electronic medical records (EMR/EHR), and automated pharmacy dispensing carousels.

Odoo Healthcare manages patient registration, doctor appointment scheduling, digital e-prescription fulfillment with drug-to-drug interaction warnings, multi-tier insurance TPA claim management, automated OPD/IPD invoice generation, and real-time pharmacy inventory depletion.

Yes. Odoo tracks Material Safety Data Sheets (MSDS), CAS numbers, specialized storage hazard classifications (flammable, toxic, biohazard), restricted customer licenses, and automated quota logging for controlled precursor chemicals.

We provide complete GAMP 5-aligned validation document packages including User Requirements Specification (URS), Functional Specification (FS), Traceability Matrix (TM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR).

We use secure, audited ETL migration scripts with double-blind hash verification to migrate SKU master formulas, vendor quality ratings, customer clinical records, legacy batch traceability logs, and opening stock balances from legacy ERPs (SAP, Infor, Microsoft Dynamics, Tally, or custom systems).

Yes. Odoo Maintenance tracks calibration schedules, filter replacement cycles, autoclave sterilization validation, HEPA differential pressure monitoring, and equipment mean time between failures (MTBF) with full technician sign-off logs.

A focused pharmaceutical distribution or medical clinic deployment takes 6 to 10 weeks. A full-scale pharmaceutical formulation manufacturing plant implementation with GAMP 5 CSV validation protocols typically spans 12 to 20 weeks.

We provide 24/7 SLA-backed hypercare, annual validation re-qualification support, regulatory audit preparation assistance, security patching, cloud backup disaster recovery testing, and continuous staff training.