Traceability
Trace graphs replace trace matrices.
Every requirement, piece of evidence, test and signature is a linked record, not a row in a spreadsheet.
Asked for the proof behind REQ-057, you answer in two clicks.
Built for buyers at
One platform for every requirement and document check. Agents for every workflow, working 24/7.
Qualitum reads your specifications, offers and evidence, compares them side by side and proves every requirement is met. Agents draft. Humans sign.
| 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 | — |
URS-014 rev. 4 received from Engineering.
Reading 4 linked documents… no action from you.
OQ-11 drafted, traced to 9 requirements.
Ready for your signature. 1 conflict flagged for review.
This is what checking three supplier offers against one specification looks like today.
| 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 |
General-purpose AI reads fast, but it can’t be trusted with a compliance decision. So the expert redoes the work, and the time saved is gone.
Every requirement has to be read, compared against the evidence and judged by someone who knows what “good” looks like. There are never enough of those people, and they never have enough time.
Hundreds of requirements checked against dozens of documents, by hand, for every project, supplier and audit.
Comparing a spec to evidence takes subject-matter experts. They are scarce, expensive and the bottleneck on every deadline.
What counts as “met”, “partial” or “missing” lives in people’s heads. Knowledge leaves when they do.
A failed audit, a warning letter, a rejected batch, a lost tender or a delayed launch. The cost of a gap dwarfs the cost of finding it.
And underneath it all, the evidence chain breaks in the same four places:
A 90-page specification hides 400 individual obligations. Nobody has ever counted them.
Test reports, certificates and drawings sit in five systems and three suppliers’ inboxes.
The compliance spreadsheet is correct the day it is signed and wrong the day after.
The missing proof is found by the auditor, the certifier or the losing bid. Not by you.
Qualitum keeps the chain intact - as data, not documents.
Every requirement is matched to a source clause, checked by several independent models that must agree, then tested against your SOPs and the current regulation. If they disagree, a human decides.
Every comparison draws on Consensus OS: your requirements, your evidence, and up-to-date regulations and guidance in one live trace. See how Consensus OS works. Or start with the industries it runs in today.
Every result shows its evidence: the document, page and clause, the version and date, and what would change the verdict. You don’t have to take our word for anything.
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.
“The evidence package is what makes it real: a system we can hand to an auditor and defend.”Head of Quality Engineering, Global Top-10 Pharmaceutical Manufacturer
“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.”
A generic chatbot can summarise a document. It cannot prove that 400 requirements are met by 30 other documents. That is the job Qualitum was built for.
General-purpose models answer confidently, skip requirements they did not notice and cite nothing an auditor can open. Qualitum checks every requirement, one by one, and links each answer to the page that proves it, or flags it as a gap.
Qualitum drafts specifications and protocols from your own past projects, SOPs and templates, not from the internet. You see exactly which sources each section came from and how closely they fit.
Today an engineer opens the URS, FS, DS, FAT and IQ/OQ in five windows and reads them line by line to check one requirement. Qualitum lines them up for the reviewer: the matching passage in each document highlighted, conflicts marked, gaps flagged, every link recorded.
A gap list you can act on, drafts ready to sign and a trace you can open in front of an auditor. Measured inside a Global Top-10 pharmaceutical manufacturer.
One agent team per job. Each step is logged, attributable and replayable. Step six is always a person.
Specifications, tenders, URS, test reports, certificates, drawings. PDF, Word, Excel or straight from your document system.
AgentOne paragraph often hides four obligations. Agents split them, tag each by risk and give it an ID you can trace.
AgentAgents read the evidence like an auditor would and link every requirement to the exact page and clause that proves it.
AgentMissing evidence, partial coverage and contradictions, each with what it would mean at audit or in the bid.
AgentTest protocols, compliance matrix answers, justifications and reports, written from your templates and linked to the source requirement.
AgentA qualified person on your side reviews every draft, edits what they want and signs. Nothing regulated moves without them.
Your qualified personChange a requirement and the affected evidence, tests and signatures light up. The audit-ready record is always one export away.
AgentQualitum works for both. Buyers check what they receive. Builders produce evidence that is already checked against what the buyer will audit.
URS, tender specifications, certification requirements. Hundreds of obligations, checked against supplier documents you did not write.
IQ/OQ, FAT/SAT protocols, test specifications, compliance matrices, manuals, declarations of conformity, certification files. For every customer, in their format.
Same evidence chain, from both ends of the handshake.
We started where the regulator is strictest. The same engine now reads the requirements and evidence of every regulated industry.
Reference deploymentComputer system validation and equipment qualification, URS to PQ, running inside a Global Top-10 pharmaceutical manufacturer.
Design history and technical files where every design input traces to verification and every software unit to a requirement.
Certification evidence where every requirement needs a verified, traceable test.
Aircraft records checked against every requirement, for pre-buy, sale readiness and ongoing compliance.
Vendor and tender compliance matrices and network equipment acceptance, checked clause by clause.
Tender compliance, product conformity and handover documentation that holds up at acceptance.
FAT/SAT, IQ/OQ packs, manuals and conformity files drafted from your own engineering data.
Requirements on one side, evidence on the other? Qualitum works on it.
Tell us about your projectTell us what you need to prove. You bring a real document set and a real deadline; we run the engine on it with your team and show you the gaps.
Pick the job you need done this quarter. The engine underneath is the same.
Prove a system or piece of equipment does what its specification says, before it goes live.
Check every bid or supplier submission against your tender before you award, clause by clause.
Map the clauses of a standard to the evidence you already hold and see exactly what is missing.
Turn your engineering data and the customer’s requirements into the deliverables they will audit.
Learned inside pharma validation, where a missing signature is a finding and a drifting matrix is a warning letter.
Every requirement, piece of evidence, test and signature is a linked record, not a row in a spreadsheet.
Agents never decide or approve. A qualified person on your side reviews and signs every regulated output.
Single-tenant, deployed inside your environment. Any LLM. EU, US or UAE residency. Air-gap capable.
Every requirement and every record is checked, every cycle, not the 1–5% a human team has time for.
| Your process today | With Qualitum | |
|---|---|---|
| Who authors | Engineers and quality staff write every protocol, matrix and report by hand. | Agents draft from your requirements and evidence. Your experts review and sign. |
| Traceability | A spreadsheet, rebuilt by hand after every change. | A live trace graph. Change a requirement and every affected item is flagged. |
| Coverage | Spot checks and samples. Gaps surface at audit. | Every requirement checked against every document, every cycle. |
| Time to first result | Weeks to months before anyone knows where the gaps are. | A gap report in 48 hours. First agent in production in 8–12 weeks. |
| Deployment | Multi-tenant SaaS or months of on-prem integration. | Single-tenant inside your perimeter. Any LLM. No content migration. |
| Audit readiness | Evidence packs assembled the week before the audit. | Audit-ready record exportable at any moment, every action attributable. |
One requirement document, one piece of evidence. We run the same engine that is live inside a Global Top-10 pharmaceutical manufacturer and send you every gap, with what it would mean at audit.
Industry-specific questions live on each industry page. The full 15-question pharma FAQ is on Life Sciences.
It reads your requirements and your evidence, breaks the requirements into testable items, matches each one to the evidence that proves it, lists every gap, drafts the missing documents and keeps a live trace. Qualified people on your side review and sign.
No. Agents draft. A qualified person reviews, approves and signs every regulated output, with an attributable e-signature. A verifier agent re-checks drafts against the source before a person sees them, but the decision is always human.
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.
Nowhere outside your perimeter. Qualitum runs single-tenant inside your cloud or on-prem environment, with EU, US or UAE residency and air-gap capability. You choose the LLM. We have no training rights and keep no data.
Two documents for the free gap report. For a pilot: one project, one requirement set and its evidence, and one qualified reviewer. Pilots run 8–12 weeks at a fixed fee.
Those systems store and route documents that people write. Qualitum does the reading, matching and drafting, and keeps the links between requirement and evidence live. You keep your existing systems. We feed them cleaner records.
A 45-minute working session with a forward-deployed engineer. Bring a real specification and a real deadline.