Qualitum is agentic computer system validation software built for regulated life-sciences teams. Validation of computer systems is one of the most labor-intensive, document-heavy obligations in a regulated manufacturing or quality environment, and Qualitum is designed to make that work faster and more consistent without cutting corners on rigor.
At its core, Qualitum helps validation engineers and quality teams plan and author Installation Qualification, Operational Qualification and Performance Qualification protocols for the software and equipment systems that run a regulated site. Rather than starting from a blank document template each time, teams can build protocols inside the platform, keep them consistent across systems, and route them through review with a clear audit trail.
A central feature of the product is its interactive trace graph, which links every requirement to the tests that verify it and to the evidence collected when those tests are executed. This end-to-end traceability is often the single hardest part of a validation effort to maintain by hand, particularly as a project grows to hundreds of requirements and test cases. By keeping that graph live and queryable, Qualitum lets a team answer audit questions about coverage and status immediately instead of reconstructing the picture from spreadsheets.
The platform is built to align with GAMP 5 and ALCOA+ principles, which are the dominant frameworks regulated life-sciences organizations already use to structure computer system validation and to judge data integrity. Qualitum does not ask teams to adopt a new methodology; it supports the one they already follow, with structure that makes that methodology easier to execute consistently.
Because the data involved in validation is sensitive, Qualitum runs single-tenant with customer-managed encryption keys, so each customer's environment and data stay isolated and under their own control. The platform connects to the systems that already hold source records and evidence for a regulated site, including Veeva, MasterControl, TrackWise, AVEVA PI and Tulip, so evidence and test results can be traced end to end without manual re-entry between systems.
Qualitum is aimed at validation engineers, quality assurance teams and other staff responsible for computer system validation at regulated life-sciences manufacturers. Typical use cases include authoring IQ, OQ and PQ protocols for a newly deployed system, tracing requirements through to executed tests ahead of an audit, and running a fixed-fee pilot on a single system before a full site rollout.
Pricing is an annual per-site licence quoted on request, and an 8 to 12 week fixed-fee pilot is available for teams that want to validate the approach on one system before committing to a broader deployment.
