Qualitum

Qualitum builds AI-native enterprise systems for regulated life-sciences companies. Its flagship product focuses on digital validation — helping heads of validation and QA/validation managers at pharma, biotech and medical-device companies replace manual, spreadsheet-based validation work with agent-authored, fully traceable documentation.

Qualitum's platform agent-authors IQ/OQ/PQ protocols directly from URS, P&IDs and SOP libraries, and builds a trace graph linking every requirement, test, signature and deviation — replacing spreadsheet requirements traceability matrices (RTMs). It runs ALCOA+ data-integrity monitoring on every record at write and review time (not just samples), applies GAMP 5 categorization and CSA-aligned risk-based testing, and deploys single-tenant in a customer's own VPC (AWS, Azure or on-prem) with customer-managed keys. Validated connectors are available to systems of record including 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 for a single system.