Qualitum

Qualitum is an agentic platform for computer system validation (CSV and CQV) in regulated life-sciences companies. It plans, authors and helps execute validation lifecycle documentation, generating IQ, OQ and PQ protocols from user requirement specifications, P and ID drawings 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 deploys single-tenant with customer-managed keys, in the customer's own AWS, Azure or on-prem environment, and connects to systems of record such as Veeva, MasterControl, TrackWise, AVEVA PI and Tulip. Built for heads of validation, QA and validation managers, and the consultancies that support regulated life-sciences manufacturing and quality operations.