Specialists in validation
ParagonV is a validation consultancy for the life science industry. We deliver commissioning, qualification and validation (CQV) for pharmaceutical, biologics, sterile manufacturing and medical device sites, from user requirements through to routine operation.
We use a scientific, risk-based approach and set strategies that are proportionate, defensible at inspection and workable once the facility is running.
What we do
- CQV for CAPEX and technology transfer projects
- Validation consultancy and training
- Gap analysis and remediation
- Qualification and requalification
- Computerised systems validation and data integrity
Where we work
- Sterile and aseptic manufacturing (EU GMP Annex 1)
- Biologics, vaccines and gene therapy
- Cleanrooms, HVAC and clean utilities
- Sterilisation and controlled storage
- Medical devices and IVDs (ISO 13485)
Valerie: protocol drafting built by validation people
Valerie is our software for drafting traceable CQV protocols from a URS. It picks the compliant route and drafts the C&Q plan, commissioning, IQ, OQ and PQ protocols and the traceability matrix, ready to use on paper, in your document management system or in a digital validation tool such as Kneat. A qualified person still reviews and approves every document before use.
Talk to us
Prefer LinkedIn? Message Laura Butchart or Wayne Oultram directly.