AI Tool

Qualitum

Agentic computer system validation for regulated life sciences

MBy Matt BaskovcLaunched Oct 19, 2026 UTC0 comments

Overview

Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences companies. It plans, authors and helps execute validation lifecycle documentation, generating IQ/OQ/PQ protocols from user requirement specifications, P&IDs and SOP libraries, and maintains a trace graph linking every requirement to its test, signature and any deviation. Every record is checked against ALCOA+ data-integrity rules at write and review time, and the platform supports GAMP 5 categorization with CSA-aligned, risk-based testing. It is deployed single-tenant with customer-managed keys, in the customer's own AWS, Azure or on-prem environment. Qualitum connects to systems of record such as Veeva, MasterControl, TrackWise, AVEVA PI and Tulip, and is built for heads of validation, QA and validation managers, and the consultancies and implementation partners that support regulated life-sciences manufacturing and quality operations.

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