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CQV / Life Sciences

CQV Intelligence Agent

GMP validation documentation. Generated, governed, and audit-ready — without the manual overhead.

FDA · EMA · MHRA · PIC/S
aligned by default
IQ/OQ/PQ
generated from equipment register
Zero reactive
requalification — all managed proactively

Why this matters

Commissioning, Qualification, and Validation — CQV — is the regulatory backbone of every pharmaceutical, biotech, and medical device operation. The documentation burden it creates is enormous and almost entirely manual. Validation Master Plans drafted from scratch. IQ/OQ/PQ protocols written individually for each piece of equipment, often replicating structure from the last protocol with manually updated parameters. Consultants spend the majority of their billable hours on documentation mechanics rather than on the engineering judgement that actually justifies their rates.


What Validate does

Validate connects to your quality management systems, document repositories, equipment registers, and regulatory knowledge base — and automates the generation, governance, review, and maintenance of the complete CQV documentation lifecycle. From Validation Master Plan through Periodic Review, every document is produced from templates aligned to current regulatory expectations, governed with full version control and audit trail, and maintained continuously rather than assembled reactively.


What's under the hood

VMP & Validation Plan Generation
Generates Validation Master Plans and project-level Validation Plans from structured input — facility scope, equipment inventory, process descriptions, applicable regulatory frameworks, and risk classification. Updates propagate automatically when scope changes.
IQ/OQ/PQ Protocol Generation
For every piece of equipment, utility system, or facility element in scope, generates structured qualification protocols with test cases, acceptance criteria, and reference values populated from the equipment register — not manually transcribed.
Risk Analysis & Impact Assessment
Supports structured risk assessments — FMEA, risk ranking and filtering, criticality classification — documented in standardised formats, linked to the qualification scope they define, maintained as living documents.
Clean Utilities & HVAC Qualification
WFI, Purified Water, Pure Steam, compressed gases, HVAC, and cleanroom qualification — protocols, sampling plans, results recording, trend analysis frameworks, and periodic requalification schedules, all governed continuously.
Periodic Requalification Management
Maintains a live requalification schedule across your entire qualified asset inventory. Monitors expiry dates, triggers workflows in advance, generates periodic review documentation from current equipment status. No qualified system expires unnoticed.

Who gets the most from Validate

Pharmaceutical and API manufacturing sites under FDA 21 CFR Part 211 and EU GMP Annex 1
Biotech and biologics manufacturers
Medical device manufacturers under ISO 13485 and EU MDR
CQV consultancies managing qualification across multiple client portfolios
CMOs with complex multi-client documentation management requirements
Deploy Validate

Ready to see Validate in your environment?

45 minutes. Your use case. Your infrastructure. We'll show you exactly how Validate would be deployed and what it would change.

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