Focus verification where it matters most.
We apply the principles of ASTM E2500, GAMP 5, and GEP to validate facilities, utilities, equipment, and computerized systems throughout the project lifecycle. By focusing verification on critical systems that affect product quality and patient safety, we eliminate unnecessary testing and documentation while ensuring full regulatory confidence from design through operational readiness. Our approach integrates engineering expertise, SME-led criticality assessments, and supplier data. We maintain complete traceability and ensure data integrity, audit trails, and compliance with Annex 11 for all digital systems. The result is a facility and digital environment that is fit for intended use, inspection-ready, and supported by robust documentation for the FDA, EMA, and MHRA.
Successful qualification is not achieved by testing everything—it is achieved by understanding what truly impacts product quality, patient safety, and regulatory compliance. At Gonvert, we apply risk-based CQV methodologies that focus verification efforts on critical systems, functions, and process parameters throughout the facility lifecycle.
Key Areas of Science-Led Risk-Based CQV Expertise:
- ASTM E2500 Risk Assessments – focusing effort on critical quality attributes
- SME-Led Criticality & Requirements Traceability – linking requirements to verification
- Risk-Based Qualification – IQ, OQ, PQ with reduced documentation burden
- GAMP 5 CSV – Category 1-5, Supplier Assessment, V-Model validation
- Data Integrity & Annex 11 – ALCOA+ principles, audit trail, access control
- Commissioning & Operational Readiness – structured startup and handover
- Deviation, Change Control & CAPA – during qualification and startup Inspection
- Readiness Support – building confidence for regulatory audits
