Qualitum

You point Qualitum at the system you need to validate and describe its intended use and regulatory context. An orchestrator agent breaks the job into the standard CSV stages and hands each to a specialist: a requirements agent captures and structures user and functional requirements, a risk agent runs the GAMP 5 risk assessment, an authoring agent drafts the qualification protocols, and an execution agent runs or scripts the tests and captures results.

• •Multi-Agent Orchestration - An orchestrator coordinates a team of purpose-built agents (requirements, risk, authoring, execution, trace and verification) so each validation stage is handled by a specialist rather than one general model
• •GxP-Aligned Evidence - Protocols, test scripts and reports follow GAMP 5, EU Annex 11 and 21 CFR Part 11 expectations, so the output is structured the way regulators and auditors expect to receive it
• •ALCOA+ Data Integrity - The platform is built around attributable, legible, contemporaneous, original and accurate records, treating data integrity as a first-class design constraint rather than an afterthought
• •Traceability Matrix Automation - A dedicated trace agent maps requirements to risks and to the tests that cover them, producing the requirements-to-test traceability that inspections hinge on
• •Validation Gap Report - A free single-package report shows where an existing system sits against validation expectations, giving teams a concrete starting point before a full engagement

Qualitum is aimed squarely at quality, validation and computer-system-validation teams inside regulated life sciences organizations - pharmaceutical manufacturers, biotech firms and medical device companies - where GxP compliance is mandatory and validation backlogs are a chronic bottleneck.