Maps standard clauses to the evidence you already hold.
Pick the standard. The Certification Agent maps every clause to the evidence you already have and shows exactly what is missing before the notified body or certifier looks.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
An AI certification agent maps the clauses of a standard or regulation to the evidence an organisation already holds, and lists the clauses that are not yet covered.
Qualitum’s Certification Agent works with standards such as ISO 13485, EU MDR, AS/EN 9100, ISO 27001 and CE directives. One evidence base can be mapped to several standards at once. A QA or regulatory lead reviews the map before it is used for certification.
Choose one or more standards. Each clause becomes a requirement.
SOPs, records, test reports and files are mapped to each clause.
Missing items listed with owners. The Drafting Agent can draft missing procedures.
Every clause of a standard linked to your evidence.
Map the same evidence to several standards at once.
Finds what you already hold before asking for more.
Each missing item assigned and tracked.
Files built from linked evidence, in the required structure.
New evidence and standard revisions update the map.
Every output links back to its sources and waits for a person to sign.
| Manual / consultants | Generic AI (ChatGPT, Copilot) | Qualitum Certification 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.
Splits any spec into testable, risk-tagged requirements.
Meet the agentLinks every requirement to the page that proves it.
Meet the agentFinds missing, partial and conflicting evidence before the auditor does.
Meet the agentWrites IQ/OQ/PQ, FAT/SAT and test specs in your templates.
Meet the agentAny standard or regulation with clauses, including ISO 13485, EU MDR, AS/EN 9100, ISO 27001, IEC 62304 and CE directives.
No. It shows what evidence covers each clause and what is missing. Certification is done by your notified body or certifier.
Yes. One evidence base is mapped to every standard you choose, so shared evidence is linked once.
Yes. It builds the file from linked evidence in the required structure, for your QA/RA lead to review.
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.