Services
Qualification and validation (CQV)
Complete support for qualification and validation in GMP environments.
Our approach
What we actually do
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.
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
Use cases and references
Technologies used:
Frequently asked questions
What is the difference between FAT, SAT, IQ and OQ?
The FAT happens at the OEM constructor's site, before shipping: it checks that the machine and its sequences work as specified in the contract. The SAT replays the critical tests on your site, once the equipment is installed and connected to utilities. The IQ then documents that the installation matches specifications and that user accounts are set up correctly. The OQ tests every sequence, recipe, alarm and safety interlock across the full operating range defined in the URS, including audit trail and 21 CFR Part 11 requirements.
What does Vanguard Systems handle, and what stays with the client or the OEM?
We prepare and run FAT and SAT protocols, lead IQ, OQ and PQ qualifications, write GAMP5 documentation and manage deviations and change control within our technical scope. Final quality sign-off, validation report approval and the site's QMS policy stay with your quality team.
How long does an IQ/OQ qualification take?
It depends entirely on the complexity of the line, there is no standard duration to quote without knowing the scope. A well-designed ISA-88 architecture shortens the OQ, because phases run independently without redeploying code for each test. The exact scoping happens in a meeting, based on how many sequences, recipes and alarms need covering.
Do you work with GAMP5 and 21 CFR Part 11 documentation?
Yes, it is the backbone of our technical documentation on every CQV mission: versioned traceability, risk analysis proportionate to system criticality, and 21 CFR Part 11 compliance for electronic signatures and audit trail. We use digital validation tools such as Kneat, Trackwise and Veeva Vault depending on what the client already has in place.
Can you support a Big Pharma internal audit or a Swissmedic, FDA or EMA inspection?
Yes, we support quality teams through internal audits at major pharma groups and through authority inspections. The documentation produced during FAT, SAT and the qualifications is structured to be directly reviewable in an audit, with full traceability of deviations and how they were resolved.
Do you work on lines involving several subcontractors and suppliers?
Yes, that is common on complex pharma line commissioning projects. We coordinate the critical qualification milestones across the different subcontractors, keep the FAT, SAT, IQ and OQ schedule on track, and centralize deviation management so a delay at one supplier does not stall the whole chain.
Contact
A project to scope out?
Tell us about your need and your timeline constraints. We come back quickly with a clear scope.