Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners

About Qualitum

Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.

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Company Information

Qualitum
qualitum.ai

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Product Details

Platforms Supported
Cloud
On-Premises

Qualitum Frequently Asked Questions

Q: What kinds of users and organization types does Qualitum work with?
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Qualitum Product Features