Qualitum
Agentic computer system validation
About Qualitum
Qualitum is an agentic computer system validation (CSV) platform built for the most heavily regulated corners of life sciences - pharmaceutical, biotech and medical device companies that must prove every piece of software touching a regulated process behaves as intended and stays in a validated state. In these industries validation is not a formality; it is a legal obligation under frameworks like GAMP 5, EU Annex 11 and 21 CFR Part 11, and it traditionally consumes armies of consultants writing requirements, risk assessments, test scripts and traceability matrices by hand. Qualitum reframes that work as something an orchestrated team of AI agents can carry, with humans reviewing and approving rather than typing every document from scratch. The pitch is simple to state and hard to deliver: keep full GxP rigor and audit-readiness while cutting the manual effort and calendar time that validation normally demands.
What makes Qualitum distinct from a generic AI writing assistant is that validation has a fixed, well-understood shape - requirements lead to risk assessment, which leads to test design, execution, evidence capture and a traceability matrix - and each of those stages maps to a specialized agent rather than a single model guessing at everything. The platform is designed around data integrity from the start, applying ALCOA+ principles (attributable, legible, contemporaneous, original, accurate and the plus set) so the evidence it produces is the kind an inspector expects, not free-form prose. It positions itself as assurance software you can hand a regulated system to and get back a defensible validation package, with the agent team doing the heavy lifting and a documented, reviewable trail behind every decision.
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. A trace agent assembles the requirements-to-test traceability matrix so nothing is left uncovered, and a verifier agent checks the package for gaps and ALCOA+ compliance before a human reviews and approves. Because the workflow mirrors how validation is actually assessed, the output lands as inspection-ready evidence rather than a draft you have to reshape. Teams can start with a free validation gap report on a single package to see where a system stands, then move to a scoped enterprise engagement for the full agentic pipeline.
- •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
- •Human-In-The-Loop Review - Every agent output is staged for human review and approval, so qualified staff sign off on the validation package and the agents accelerate the work rather than replace accountability
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. It fits validation engineers and CSV specialists who spend weeks authoring protocols and traceability matrices by hand, quality assurance leaders accountable for audit-readiness, and regulatory and compliance functions that must defend the validated state of their systems to inspectors. Because it is scoped as an annual enterprise engagement rather than a self-serve tool, it suits mid-size and larger organizations with recurring validation needs and the internal quality oversight to review agent output, rather than an individual or a startup dabbling in compliance. The free validation gap report also makes it a fit for teams that want an evidence-based read on where a specific system stands before committing to a program.
Pricing
Custom pricing, contact sales
Annual enterprise licence, quote-only (scoped by system, footprint and assurance level). Free single-package validation gap report; no self-serve paid tier.
From the vendor pricing page, 2026-09-28
