Qualitum is agentic computer system validation (CSV) software built for regulated life-sciences teams who need to qualify and maintain computerized systems under GxP and GAMP 5 expectations. Instead of validation engineers manually drafting documents and chasing traceability across spreadsheets, Qualitum uses AI agents to author validation deliverables end to end while keeping every artifact anchored to verifiable evidence.
At the core of the platform is agent-authored protocol generation. Qualitum's agents draft Installation Qualification, Operational Qualification, and Performance Qualification protocols directly from a system's configuration and intended use, producing test steps, acceptance criteria, and expected results that validation leads can review, edit, and approve rather than write from scratch. This shortens the time between a system going live and its validation package being audit-ready.
Traceability is built into the data model, not bolted on afterward. Every requirement links to the tests that verify it, every test links to its execution record and any resulting deviation, and every signature is tied to the specific version of the artifact it approved. This trace graph means a validation lead or auditor can start from a single requirement and follow it through to objective evidence, or start from a deviation and trace backward to the requirement it affects, without manually cross-referencing spreadsheets.
Qualitum continuously monitors data integrity against the ALCOA+ principles, attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available, at the moment records are written and again at review time, rather than relying solely on an end-of-cycle audit. Systems are categorized under GAMP 5, and testing depth is calibrated using a risk-based approach aligned with Computer Software Assurance guidance, so low-risk configured functions get lighter testing while high-risk custom logic gets closer scrutiny.
On the infrastructure side, Qualitum is designed for organizations that cannot compromise on data residency or control. The platform runs single-tenant, deployable on AWS, Azure, or on-premises infrastructure, with customer-managed encryption keys so the customer, not Qualitum, holds the ultimate ability to access or revoke access to their validation data.
Qualitum ships with validated connectors to the systems life-sciences quality and manufacturing teams already run on, including Veeva, MasterControl, TrackWise, AVEVA PI, and Tulip. These connectors let evidence, test results, and deviations flow between Qualitum and the source system of record without manual re-entry, closing a common gap where validation evidence and operational systems drift out of sync over time.
Qualitum is built for validation leads, quality assurance teams, and IT teams inside pharmaceutical, biotech, and medical device companies who are responsible for keeping computerized systems in a validated state across their lifecycle, from initial qualification through periodic review and eventual retirement.
Pricing is structured as an annual per-site licence, quoted on request based on the number and complexity of systems being validated. For teams that want to evaluate the platform on a real system before committing to a full rollout, Qualitum offers an eight to twelve week fixed-fee pilot covering a single system, letting a quality or validation team see the full protocol authoring and traceability workflow on their own equipment before scaling to the rest of their portfolio.
