Classifies systems under GAMP 5, with the rationale.
Describe the system. The GAMP Agent proposes the GAMP 5 category, scores risk per requirement and writes down why, so your validation lead can confirm or change it in minutes.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
An AI GAMP agent proposes the GAMP 5 software category of a computerised system and scores the risk of each requirement. It explains its reasoning so a validation lead can confirm or change the decision.
Qualitum’s GAMP Agent reads the URS, functional spec and vendor documents, looks for configuration and custom code, and writes a rationale tied to the source pages. A first-pass version is available as a public API. Inside a deployment, every category is reviewer-confirmed.
Upload the URS, FS and vendor documents, or just describe the system.
Category proposed per system and module. Risk scored per requirement.
Your validation lead reviews the rationale and confirms or changes the category.
Category 1, 3, 4 or 5 proposed per system and module.
Why, with the source pages behind each point.
ICH Q9 risk scoring on each requirement.
Finds bespoke modules inside configured systems.
One rule set, applied the same way everywhere.
First-pass category check callable without an account.
Every output links back to its sources and waits for a person to sign.
| Manual / consultants | Generic AI (ChatGPT, Copilot) | Qualitum GAMP 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 agentWrites IQ/OQ/PQ, FAT/SAT and test specs in your templates.
Meet the agentLinks every requirement to the page that proves it.
Meet the agentKeeps a live trace graph and flags everything a change touches.
Meet the agentNo. It is a proposal with a rationale. Your validation lead confirms or changes it, and the decision is recorded.
Yes. A first-pass check is available at POST https://qualitum.ai/api/v1/gamp-category-check. It is indicative only.
Yes. Risk is scored per requirement using ICH Q9 principles, or your own risk procedure.
Each module is classified separately, so custom code inside a configured system is called out.
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.