One platform for every requirement and document check. Agents for every workflow, working 24/7.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
| Requirement | Clause | Evidence |
|---|---|---|
| Operating range −20 to +55 °C | §3.2.1 | TR-118 §4.2 |
| Data retained for 10 years | §6.1.3 | FS §2.1 |
| Audit trail export to PDF/A | §6.1.7 | — |
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 | 7.2.4 | Part 11 e-signature | Comply | Comply | check OQ |
| 6 | 8.4.1 | Changeover < 15 min | Deviation | pending | |
| 7 | 9.1.2 | Noise < 70 dB(A) | Comply | who checks? |
Records shall be retained for 7 10 years and be retrievable…
| Criterion | A | B | C |
|---|---|---|---|
| Throughput | 300/min | 280/min | ? |
| 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.
Every product that reaches a patient, a plane or a power grid stands on quality assurance. It is the standard customers trust and auditors test. When it slips, one missed line can sink a launch, a batch or a brand.
Doing QA properly takes rare people: auditors, validation engineers and subject-matter experts for every standard, applied to every document, every time. No team can hire enough of them.
So we built Qualitum: an AI Chief Quality Officer with a swarm of agents that learn your company’s knowledge and do 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.
| Requirement | URS rev. 4 | Supplier A | Supplier B | Supplier C |
|---|---|---|---|---|
| 3.2.1 Operating range | −20…+55 °C | MetTR-118 §4.2 | MetSpec p.12 | Partial+45 °C only |
| 4.2.7 Reject verification | Every pack | MetFS-M04 §3.1 | Metp.22 | Metp.9 |
| 6.1.3 Data retention | 10 years | MetFS §2.4 | Conflict7 years, p.31 | Metp.14 |
| 6.1.7 Audit trail PDF/A | Required | MetOQ-23 | Metp.33 | GapNo evidence |
| 8.4.1 Changeover | < 15 min | Partial18 min, p.40 | Metp.45 | Metp.21 |
| Score | 312 req. | 291 met | 274 met | 184 met |
Before anything is compared, every document is normalised to the same requirement, the same unit and the same language. Only then is it scored.
Checks every bid against every requirement, with the passage behind each answer.
Meet the agentDrafts URS, specs and tender packages from your process inputs, standards and past projects.
Meet the agentChecks your RFI or RFP response against the customer’s request before you submit.
Meet the agentMaps SOPs, systems and QMS against GMP, Annex 11, ISO 13485 or NESAS and lists every gap.
Meet the agentBuilds the requirement-to-test-to-evidence matrix as work happens and shows what a change touches.
Meet the agentMatches contract, PO and invoice on price and terms before payment is released.
Join the design partner listChecks ledger entries and spend against their supporting evidence and rules.
Join the design partner list
Three steps, every time. See the full engine.
Requirements, SOPs, templates and regulations. Nothing from the open internet.
Each result links to its source. Models must agree, or a person decides.
| Req. | A | B | C |
|---|---|---|---|
| 3.2.1 Range | |||
| 6.1.3 Retention | |||
| 6.1.7 Audit trail |
Every draft, check and signature is recorded and ready for the auditor.
“We’ve cut more than 50% of the time out of our validation process, and the cost saving has been enormous. The evidence package is what makes it real: a system we can hand to an auditor and defend.”

Measured inside a Global Top-10 pharmaceutical manufacturer.
Reference deploymentCSV and equipment qualification, URS to PQ. Live inside a Global Top-10 pharma.
Design inputs traced to verification. Technical files from your evidence.
Every certification requirement traced to a verified test.
Aircraft records checked for pre-buy and sale readiness.
Vendor tenders and network acceptance, clause by clause.
Tender compliance, CE/EN conformity and handover files.
FAT/SAT, IQ/OQ packs and conformity files from your data.
Trace graphsEvery answer in two clicks.
Humans signAgents never approve.
Your perimeterSingle-tenant, any LLM.
100% reviewedEvery record, not a sample.
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.