Qualitum is an agentic platform for computer system validation (CSV and CQV) in regulated life-sciences companies, built for heads of validation, QA and validation managers, and the consultancies and implementation partners that support regulated life-sciences manufacturing and quality operations.
The platform plans, authors and helps execute validation lifecycle documentation. It generates IQ, OQ and PQ protocols directly from user requirement specifications, P and ID drawings and SOP libraries, replacing the manual drafting that normally consumes weeks of a validation team's time. A trace graph links every requirement to its corresponding test, signature and any deviation, taking the place of spreadsheet-based requirements traceability matrices that are error-prone to maintain by hand.
Qualitum applies ALCOA+ data-integrity monitoring to every record at the moment it is written and reviewed, rather than through periodic sampling, and supports GAMP 5 categorization together with CSA-aligned, risk-based testing approaches.
Because validation data is highly sensitive, Qualitum deploys single-tenant, in the customer's own AWS, Azure or on-prem environment, with customer-managed encryption keys, so validation records never leave the customer's control. The platform includes validated connectors to common systems of record such as Veeva, MasterControl, TrackWise, AVEVA PI and Tulip, so validation packages can be produced and evidenced without exporting data to a shared multi-tenant service.
Pricing is an annual per-site licence, quoted on request, with an 8-12 week fixed-fee pilot available covering a single system, letting a validation team see full lifecycle documentation for one real system before committing to a broader rollout.
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