2024-06-01
Regulatory Requirements Mapping
GxP requirements and audit findings from previous cycle documented with the QA team.
BioPharma Labs conducts clinical testing and needed end-to-end sample traceability.
Paper-based sample tracking caused compliance risks and test result delays.
Odoo.sh with Inventory lot tracking, Manufacturing and a custom LIMS integration for full sample lifecycle management.
Full sample traceability achieved. Regulatory audit passed without findings.
BioPharma Labs now operates with the documentation rigour required by the most demanding regulatory agencies. The integration between Odoo and their LIMS gives scientists the data they need and auditors the trail they require — all in one system.
2024-06-01
GxP requirements and audit findings from previous cycle documented with the QA team.
2024-07-15
Data flows between Odoo and LIMS designed. Electronic batch record structure approved by QA.
2024-08-15
Odoo.sh deployed. Custom LIMS integration developed. IQ/OQ/PQ validation protocol executed.
2024-10-15
Internal regulatory review completed. All validation documents submitted and approved.
2024-12-01
Go-live with full validation package. First external audit scheduled for Q1 2025.
"We passed our first full regulatory audit with zero findings."