From URS & DS to GMP-compliant protocols in minutes, not weeks
Valerie is the AI copilot for CQV teams. Upload your User Requirement Specifications and Design Specifications, and get audit-ready IQ, OQ, and PQ protocols reviewed by CQV SMEs — not black-box AI.
Built for pharma, medical device & life sciences CQV teams.
How it works
Requirements in. Compliant protocols out.
Valerie combines generative AI with expert human oversight so your CQV documentation is fast, defensible, and inspection-ready.
Upload your URS & DS
Drop in your User Requirement Specification and Design Specification documents in whatever format you already have them — Word, PDF, or Excel.
Valerie drafts the protocol
Our AI engine maps every requirement to test cases, generating structured IQ, OQ, and PQ protocols aligned to GAMP 5 and your quality standards.
SMEs review & refine
CQV subject-matter experts review, edit, and approve every generated protocol before it reaches your document control system — no AI black box.
Export, execute, done
Export audit-ready, GMP-compliant protocols directly into your QMS or eQMS, with full traceability from requirement to test step.
Pricing
Built for the pace of CAPEX. Priced for the people doing the work.
Individual
For a single CQV professional — contractor or in-house — handling their own protocol workload.
- Single user
- 4 protocol suites / month
- URS & DS upload and parsing
- Standard export formats
Team
For a small team of protocol writers working across a shared project or programme.
- 3 user seats
- 4 protocol suites per seat (12 total)
- URS & DS upload and parsing
- Everything in Individual
Enterprise
For larger organisations or multi-team programmes. Get in touch for a tailored plan.
- Custom seat count
- Custom suite volume
- URS & DS upload and parsing
- Everything in Team
- Dedicated onboarding and support
FAQ
Frequently asked questions
Valerie is an AI copilot for CQV (Commissioning, Qualification & Validation) teams. Upload your User Requirement Specifications and Design Specifications, and Valerie generates audit-ready protocols, reviewed by CQV SMEs before they reach your document control system.
Ready to validate faster?
Join the CQV teams cutting protocol drafting time from weeks to minutes — without compromising on compliance.