Qualitum

Qualitum is agentic computer system validation for regulated life-sciences manufacturers. Its Validate·AI system authors, executes and defends IQ/OQ/PQ protocols under GAMP 5, ALCOA+ and 21 CFR Part 11, replacing spreadsheet-driven CSV/CQV work. A trace graph links every requirement, test, signature and deviation, giving validation leads and QA/IT teams in pharma, biotech and medical-device companies full audit-ready traceability. Deployment is single-tenant (AWS, Azure or on-prem) with customer-managed keys, and validated connectors exist for Veeva, MasterControl, TrackWise, AVEVA PI and Tulip. Pricing is an annual per-site licence quoted on request, with an 8-12 week fixed-fee pilot available.