Qualitum is an agentic platform for computer system validation (CSV and CQV) in regulated life-sciences companies. It authors IQ, OQ and PQ protocols, keeps a trace graph from requirement to test to signature, checks every record against ALCOA+ rules, and supports GAMP 5 categorization with CSA-aligned testing. It deploys single-tenant with customer-managed keys and connects to Veeva, MasterControl, TrackWise, AVEVA PI and Tulip.

Our founder has a background in biotech before moving into technology, with two prior startup exits. Validation teams in regulated life sciences still write most protocols and evidence packages by hand, which is slow and error-prone. Qualitum was built to make that work agent-assisted while staying fully auditable.
