Bids against the spec. Your response against the RFP. SOPs against the standard. Every verdict linked to its source passage, and a person signs.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
Quality assurance should prevent mistakes before they happen. Today it still means people reading thousands of pages by hand, like checking three supplier offers against one specification.
| URS clause | Requirement | Supplier A | Supplier B | Comment | |
|---|---|---|---|---|---|
| 1 | 3.2.1 | Operating range | Comply | Comply | see TR? |
| 2 | 4.2.7 | Reject verification | Comply | ?? | ask vendor |
| 3 | 6.1.3 | Data retention 10y | Comply | Partial | 7y in FS? |
| 4 | 6.1.7 | Audit trail PDF/A | #REF! | Comply | |
| 5 | 8.4.1 | Changeover < 15 min | Deviation | pending |
Records shall be retained for 7 10 years and be retrievable…
| Criterion | A | B | C |
|---|---|---|---|
| Retention | 10 y | 7 y | #N/A |
| Changeover | 18 min | 12 min | 14 min |
| Price | €1.2M | €0.98M | €1.1M |
Hundreds of requirements checked against dozens of documents, line by line, by hand.
Only a few people can judge a spec against evidence. They are the bottleneck on every deadline.
What counts as met, partial or missing lives in people’s heads. It leaves when they do.
A failed audit, a rejected batch or a lost tender costs far more than finding the gap.
Quality is the 1% that makes or breaks a company. Until now, only the biggest could afford to get it right.
One missed line can sink a launch, a batch or a brand. Doing QA properly takes rare experts for every standard and every document. No team can hire enough of them.
So we built Qualitum: an AI Chief Quality Officer that does the expert work, with proof behind every answer.
ChatGPT gives you a best guess. Qualitum gives you audit-ready proof.
87% of buying decisions made with frontier AI models still get re-checked by a person. In B2B it is every decision, by hand. When an answer has even a 1% chance of being wrong, the consequences are brutal. And someone has to sign for it.
Qualitum reads every document and puts them in one structured comparison. Every cell traced to its source page. One place for all the work.
10× faster bid comparison
Weeks off the first draft
100% of lines matched
Every mandatory item checked
100% of entries reviewed
2 clicks from any answer to its proof
Weeks of mapping, done first
70% less authoring on IQ/OQ/PQ
100% of records reviewedEvery source compared on the same terms, so gaps surface before they cost money.
“We’ve cut more than 50% of the time out of our validation process. The evidence package is a system we can hand to an auditor and defend.”
Send one requirement document and one piece of evidence. The same agents that run inside a Global Top-10 pharmaceutical manufacturer find every gap and tell you what it would mean at audit. You get the report in 48 hours.
A team of AI agents that does the reading, comparing, gap-finding and drafting work of a quality department, 24/7. Every answer is traced to the page that proves it. Your AI CQO prepares. Your qualified person signs.
No. Agents prepare and check. A qualified person on your side reviews, approves and signs every regulated output with an attributable e-signature. The Verifier Agent re-checks drafts before a person sees them, but the decision is always human.
A general chatbot gives you an answer. Qualitum checks every requirement one by one, against every document, and links each result to the page and clause that proves it. If there is no proof, it is a gap. Several models must agree before a result is shown.
Nowhere outside your perimeter. Qualitum runs single-tenant inside your cloud or on-prem, with EU, US or UAE residency and air-gap capability. You choose the model. We have no training rights and keep no data.
Any industry where requirements must be proven with evidence: life sciences, medical devices, aerospace, aviation, telecom, construction and industrial machinery. Our reference deployment is inside a Global Top-10 pharmaceutical manufacturer; the results we quote come from there.
Two documents for the free gap report. For a pilot: one project, one requirement set and its evidence, and one qualified reviewer. First agent in production in 8 to 12 weeks.