Splits any spec into testable, risk-tagged requirements.
One paragraph of a specification often hides four obligations. The Requirements Agent finds each one, gives it an ID, tags its risk and links it to the clause it came from.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
An AI requirements agent reads a specification and breaks it into individual, testable requirements. Each one gets a unique ID, a link to the source clause, a risk level and a note on how it could be verified.
Qualitum’s Requirements Agent works on URS, tender specifications, standards and customer specs. It flags requirements that cannot be tested as written and keeps IDs stable when the document is revised, so the trace does not break.
Any URS, tender or standard, in PDF, Word or Excel.
Every obligation becomes one requirement with an ID, a risk level and a verification method.
Unclear items go to a person. Clean items go to the Evidence Agent.
One obligation per requirement, each with its source clause.
Your risk rules, GAMP 5 or ICH Q9, applied on intake.
Vague words flagged, with a suggested measurable rewrite.
Revisions compared; added, changed and removed items shown.
Repeated or contradicting requirements found across the spec.
URS, tenders, standards, customer specs, in several languages.
Every output links back to its sources and waits for a person to sign.
| Manual / consultants | Generic AI (ChatGPT, Copilot) | Qualitum Requirements Agent | |
|---|---|---|---|
| Sources cited | Sometimes, in comments | Rarely, and often wrong | Every answer, with page and clause |
| 100% coverage | Sampled when time runs out | Skips what it does not notice | Every requirement, every cycle |
| Works in your templates | Yes, by hand | Generic format | Your templates and numbering |
| Runs in your perimeter | Yes | Usually public cloud | Single-tenant, air-gap capable |
| Audit trail | Partial, kept by hand | None | Every action attributable |
| Human sign-off | Yes | Not enforced | Always. Agents prepare, people sign. |
Every agent reads the same Consensus OS knowledge graph, so work moves between them without re-reading.
Links every requirement to the page that proves it.
Meet the agentFinds missing, partial and conflicting evidence before the auditor does.
Meet the agentClassifies systems under GAMP 5, with the rationale.
Meet the agentAnswers or checks tenders, clause by clause.
Meet the agentNo. It proposes rewrites for unclear requirements. Your team decides what changes in the source document.
Yes. It applies your risk procedure, or GAMP 5 and ICH Q9 if you have none.
It compares the new version with the old one, keeps IDs stable and shows exactly what was added, changed or removed.
URS, functional specs, tenders, standards and customer specs, in PDF, Word, Excel or scans, in several languages.
No. It prepares and checks. A qualified person on your side reviews, approves and signs every regulated output. Your AI CQO prepares. Your qualified person signs.
Nowhere outside your perimeter. Qualitum runs single-tenant inside your cloud or on-prem, with EU, US or UAE residency and air-gap capability. No training on your data, no retention.
The one you choose. Consensus OS sits on top of any frontier or open model, and the Verifier Agent checks results across several models.
Send two documents for a free gap report in 48 hours. A pilot runs 8 to 12 weeks on one real project, with one qualified reviewer from your team.