Built for Heads of Validation and QA at pharma, biotech and medical-device manufacturers. Deployed inside your own perimeter, under GAMP 5, EudraLex Annex 11 and 21 CFR Part 11.
One platform for the full computer system validation lifecycle — CSV and CQV, URS to PQ. Agents do the authoring and execution; your qualified people review and sign.
Agents draft URS, risk assessments, IQ/OQ/PQ protocols and summary reports from your specifications and templates. First drafts arrive in minutes instead of weeks, ready for expert review.
Test steps are executed and evidenced with a tamper-evident audit trail. Deviations are flagged in context, so reviewers see what failed and why.
A live trace graph links every requirement to its risk, test and result. When a requirement changes, impacted tests are identified automatically instead of rebuilt by hand.
Systems are categorised and requirements scored under ICH Q9. Try a first-pass GAMP 5 check free, with no login.
SOPs, batch records and audit-trail review are authored and checked against ALCOA+. The result is consistent documentation that holds up across sites.
An exportable, cross-referenced evidence package for FDA, EMA, MHRA, PMDA or ANVISA inspection. Available at any moment, not assembled the week before.
Most digital validation tools moved the paper process into a browser. Qualitum changes who does the work.
Paperless validation platforms such as Kneat, ValGenesis, Sware Res_Q and Veeva Vault Validation digitise protocols, but people still write every line. In Qualitum, agents produce the first draft of each deliverable and people approve it, cutting validation cycle time roughly in half.
Qualitum deploys single-tenant in your own environment, with customer-managed keys and no data egress. Air-gapped deployment is supported, which multi-tenant SaaS validation tools typically cannot offer.
Secure deployment in your own environment takes one to two weeks of engineering, and validation time is cut roughly in half. Legacy digital-validation rollouts commonly run over several quarters before the first system is validated on them.
One annual licence, scoped by site footprint, with no per-user or per-document overages. Your cost stays predictable as more of the team uses the platform.
Qualitum is the quality layer above the model, not a model vendor, and runs on any LLM you choose. Test-automation suites such as Tricentis automate execution; Qualitum covers the validation deliverables around it. It sits on top of your existing QMS rather than replacing it, and your records stay exportable in open formats.
Built by an ISO 27001 Lead Auditor-led team: ISO 27001-aligned, 24/7 SOC, penetration testing and a full audit log ship with every deployment. Security is not an add-on module.
Teams that validate GxP computerised systems and answer to an inspector.
Qualitum is built by validation engineers, software engineers and regulatory specialists from the Benchmarked group, a network of 40+ operators in Ljubljana, New York, Utah, Dubai and Zagreb that co-builds and co-operates AI-native companies.
Founder & CEO
Matt has spent his career building security for regulated industries — post-quantum cryptography, machine identity, and secure payments scaled past $1.2B in transactions — with two founder exits behind him. An ISO 27001 Lead Auditor and former fractional CISO, he founded Benchmarked Group, where the workflow behind Qualitum was first proven with a top-10 pharma company.
Co-founder & CTO
Žiga is a cofounder of Benchmarked and of Zero Days, a Ljubljana R&D and engineering studio, where he led the build of the AI validation workflow now running in production at a top-10 pharma company. At Qualitum he owns the platform architecture and the quality layer: evals, guardrails and traceability that make AI output audit-ready.
Validation work inside pharma was taking quarters, and most of that time went into writing and cross-referencing documents rather than testing systems. We built Qualitum so agents could handle that authoring while qualified people keep control of every approval.
Qualitum launched in 2026, co-built on Benchmarked’s Venture OS platform with forward-deployed engineers, and is still co-operated by the group. Qualitum is now in production at two global top-10 pharmaceutical manufacturers. The team behind it has delivered for Sidra Medicine, RMI, Liburnia Group, Excellerate Energy, EKWB and Robotina through Benchmarked Group.
A named validation engineer works with you from the first call to the first audited package.
A 45-minute session with a validation engineer on one of your real systems. Book it here.
We agree scope by site footprint and fix the commercial model: one licence, one implementation, one annual assurance figure.
Private deployment in your environment in 1–2 weeks of engineering, on the LLM of your choice. Then your first system from URS to audited PQ.
A named validation engineer and a named support engineer on rotation. Your QA team stays the signatory on every record.
Email hello@qualitum.ai or support@qualitum.ai, or log a ticket via Support. Sev-1 acknowledged in 15 minutes, Sev-2 in 2 hours, Sev-3 within 1 business day.
| Company name | Qualitum |
|---|---|
| Type | Agentic computer system validation (CSV/CQV) software for life sciences; B2B enterprise |
| Founded | Benchmarked d.o.o. established 2003; Qualitum launched 2026 |
| Founder | Matt (Matevž) Baškovc, Founder & CEO; co-founder Žiga Patačko, CTO |
| Headquarters | Ljubljana, Slovenia, EU; group offices in New York, Utah, Dubai and Zagreb |
| Website | qualitum.ai |
| Core offering | AI agents that author, execute and defend the validation lifecycle from URS to PQ under GAMP 5, EudraLex Annex 11 and 21 CFR Part 11 |
| Pricing | Annual licence scoped by site footprint; quoted on request (pricing) |
| Contract terms | Annual licence with a fixed implementation fee and annual assurance; no per-seat or per-token overages |
| Services | Validation authoring, protocol execution, traceability, GAMP 5 categorisation and risk scoring, GMP procedure authoring, ALCOA+ data-integrity review, inspection defence packs |
| Communication | Email (hello@, support@, security@qualitum.ai), support ticketing, named engineers; SLA-backed response (Sev-1 acknowledged in 15 min) |
| Notable clients | Two global top-10 pharmaceutical manufacturers (under NDA). Team track record via Benchmarked Group: Sidra Medicine, RMI, Liburnia Group, Excellerate Energy, EKWB, Robotina |
| Customers served | In production at two global top-10 pharmaceutical manufacturers; serves pharma, biotech, medical-device, CDMO and CRO validation teams |
| Projects delivered | Built by the Benchmarked Group team: 10+ systems and ventures operated, 40+ embedded experts, every build delivered in a regulated environment |
| Proof points | Validation time cut roughly in half (2x faster); secure deployment in 1–2 weeks of engineering; runs private on any LLM; ISO 27001-aligned, 24/7 SOC, penetration testing, full audit log; rated 4.9 on Clutch |
| Parent group | Benchmarked, which also operates Procurato, wiz.legal, Knowledge Layer, Cryptera and Verne Marine |
| Competitors | Kneat, ValGenesis, Sware Res_Q, Veeva Vault Validation, Tricentis, and manual document-based validation |
| Social | Matt Baškovc on LinkedIn · Benchmarked on LinkedIn · Benchmarked on Clutch (4.9) · Benchmarked d.o.o. on Bizi.si |
Qualitum is an agentic computer system validation platform for life sciences. AI agents author and execute the validation lifecycle from URS to PQ, and qualified people review and sign.
No. Qualitum sits above your existing QMS and document systems and does not replace them.
Inside your own perimeter. Qualitum deploys single-tenant in your environment with customer-managed keys and no data egress; air-gapped deployment is supported. See Security.
Qualitum is licensed annually and scoped by site footprint, not by seat or token. Pricing is quoted after a scoping session.
Your qualified personnel. Agents draft and execute; review, approval and electronic signature ownership stay with your QA team.
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.