Compliance & audits
Qualitum
AI agent teams that turn requirements and evidence into audit-ready compliance validation
An agentic computer system validation platform that authors, executes and defends IQ/OQ/PQ protocols for life sciences companies under GAMP 5, Annex 11 and 21
Overview
A look at qualitum.ai
Qualitum is an agentic validation platform that helps life sciences teams prove every requirement is met. AI agents read specifications and evidence, decompose requirements into testable items, match each to supporting documentation, identify gaps, and draft missing documents—all while maintaining a complete audit trail. Qualified people review and sign every output.
The platform deploys as a private single-tenant system inside your infrastructure with no data egress, supporting pharmaceutical manufacturers, biotech companies, medical-device makers, CDMOs and CROs. It covers the full validation lifecycle from user requirements specifications through performance qualification, plus GMP procedures, batch records and ALCOA+ data-integrity checks.
Qualitum reduces validation cycle time by roughly half compared to manual processes, with deployment taking 1–2 weeks of engineering. The system runs on any large language model of your choice and integrates above existing QMS platforms rather than replacing them.
Feature notes
- Requirement decomposition and matching to evidence
- Gap identification and document drafting
- Full CSV/CQV lifecycle from URS to PQ
- GAMP 5 categorisation and ICH Q9 risk scoring
- Human approval with electronic signature
- Private single-tenant deployment with no data egress
Pricing
Pricing model: Contact for pricing
Annual licence priced by site footprint and scope of automation, with fixed implementation fee and annual assurance. Contact for specific rates.
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FAQ
- What does Qualitum actually do?
- Qualitum reads your requirements and evidence, breaks requirements into testable items, matches each to evidence that proves it, lists gaps, drafts missing documents and keeps a live trace. Qualified people review and sign every output.
- Does the AI approve or sign anything?
- No. Agents draft and execute, but qualified people on your side review, approve and sign every regulated output. Nothing regulated moves without human sign-off.
- Where is our data processed?
- Inside your own perimeter. Qualitum deploys as a single-tenant system in your environment with customer-managed keys and no data egress. Air-gapped deployment is also supported.
- How fast can we get started?
- Most teams start with a 45-minute working session. Secure deployment in your environment then takes 1–2 weeks of engineering, and validation time drops by roughly half.
- Who signs the validation records?
- Your qualified personnel. Agents draft and execute; review, approval and electronic signature ownership stay with your QA team.
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