Validation docs, source-traced and audit-ready.
IQ, OQ, and PQ protocols and reports drafted from your plan, requirements, and executed results — with traceability matrices and an expert review before delivery.
Documents an auditor can follow.
IQ / OQ / PQ protocols
Installation, operational, and performance qualification protocols drafted from your validation plan and requirements.
Validation reports
Reports drafted from your executed results, with each statement traced to the data behind it.
Traceability matrices
Requirement-to-test traceability so an auditor can follow each requirement to the evidence for it.
Who it's for
- Pharma and biotech quality and validation teams
- CROs and CDMOs validating systems for sponsors
- Teams preparing for 21 CFR Part 11-aware audits
What to send
- Your validation plan and requirements
- Executed results (for reports)
- Existing protocols and reports (for review)
Timeline & format
- Confirmed on the scoping call
- Delivered as source-traced documents
- Expert-reviewed before it reaches you
Deterministic checks are kept separate from AI-assisted reasoning, and the deliverable names which produced which finding. We write “not located in supplied documents,” not “does not exist,” unless we have authoritative knowledge that it does not.
Request validation documentation.
Tell us what you are working on. We will tell you what a scoped engagement would cover and how it would be priced.