Finds missing, partial and conflicting evidence before the auditor does.
The Gap Agent checks every requirement against every piece of evidence you hold. Whatever is not proven, it names, with the page it looked at and what the gap would mean at audit.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
An AI gap agent is software that compares a set of requirements against a set of evidence documents and lists every requirement that is not fully proven. It sorts each one as missing, partial or conflicting, and links the result to the exact page and clause it checked.
Qualitum’s Gap Agent does this for validation, procurement and certification work. It reads PDFs, Word, Excel and scans in several languages, checks every requirement rather than a sample, and hands the gap report to a qualified person to review. It never closes a gap on its own.
Drop in the requirement document and the evidence. The Requirements Agent splits the spec into testable items first.
Each requirement is tested against every document. Several models must agree on the status before it is shown.
You get a gap list sorted by risk. The Drafting Agent can draft the missing test for each gap.
Three gap types, each with what is missing and where it looked.
High-risk gaps first, using your risk rules or GAMP 5 / ICH Q9.
PDF, Word, Excel and scans. German, French and Italian read with English.
°C, years, minutes and dB(A) converted before comparison.
Several models must agree on every status. Disagreement goes to a person.
Each gap says what it would mean at audit, in the bid or at FAT.
Every output links back to its sources and waits for a person to sign.
| Manual / consultants | Generic AI (ChatGPT, Copilot) | Qualitum Gap 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 agentWrites IQ/OQ/PQ, FAT/SAT and test specs in your templates.
Meet the agentRe-checks every draft against its source with multi-model consensus.
Meet the agentA requirement with no evidence, evidence that covers only part of it, or two documents that contradict each other. Claims without a page count as gaps.
It checks all of them. Sampling is what people do when there is no time. The agent checks every requirement against every document, every cycle.
For the free report, 48 hours from receiving your two files. Inside a deployment, minutes for most document sets.
No. It names them and can draft a fix through the Drafting Agent. A person decides whether the gap is closed.
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.