Qualification and validation (CQV)

Complete support for qualification and validation in GMP environments: Factory Acceptance Test, Site Acceptance Test, installation, operational and performance qualification. GAMP5 and 21 CFR Part 11 compliant documentation, deviation management, support for Big Pharma internal audits and authority inspections. For missions requiring dual batch and CSV expertise, we work with our partner Eric Rouane (20+ years pharma CQV).

Our Expertise

Factory Acceptance Test (FAT) preparation and execution at OEM constructors

Site Acceptance Test (SAT) at client site after installation and utility connection

Installation, Operational and Performance Qualification (IQ/OQ/PQ)

Versioned and traceable technical documentation per GAMP5

Deviation, CAPA and change control management in regulated environments

Digital validation tools: Kneat, Trackwise, Veeva Vault

Big Pharma internal audits and Swissmedic / FDA / EMA inspections support

Multi-subcontractor coordination on critical qualification milestones

Technologies

FATSATIQ / OQ / PQGAMP521 CFR Part 11ISA-88KneatTrackwiseVeeva Vault

Use Cases & References

Complete commissioning and qualification of a fill & finish line

End-to-end engagement on a new pharma fill & finish line: Factory Acceptance Test preparation and execution at the constructor, Site Acceptance Test on a Swiss site, Installation Qualification then Operational Qualification through to routine production. GAMP5 and 21 CFR Part 11 compliant documentation, ready for Swissmedic and FDA audits.

Technologies used:

FAT / SATIQ / OQGAMP521 CFR Part 11KneatTrackwise