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. Pricing is an annual per-site licence, quoted on request. Validation managers use Qualitum to shorten the time between a change in a regulated system and a fully signed-off, audit-ready package, while keeping every artifact traceable back to its source requirement. The platform is designed for teams supporting GxP-regulated environments where manual protocol writing and evidence assembly consume the majority of a validation cycle. It is built for regulated life-sciences quality and IT teams.
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