Writes IQ/OQ/PQ, FAT/SAT and test specs in your templates.
The Drafting Agent writes the documents your engineers spend weeks on, from your own requirements, past projects and templates. Every section links to the requirement it answers.
Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.
An AI drafting agent writes regulated documents, such as IQ/OQ/PQ protocols, FAT/SAT protocols and test specifications, from a set of requirements and a template. Each section is linked to the requirement it answers.
Qualitum’s Drafting Agent uses your own knowledge base: past projects, SOPs and templates, not text from the internet. It shows which sources each section came from. The Verifier Agent re-checks every draft before your engineer reviews and signs it.
Choose the document type, the template and the requirements it must cover.
The agent pulls from past projects and SOPs that fit, and shows how closely each source matches.
The Verifier Agent checks every step against its source. Your engineer edits and signs.
Your numbering, headers, fields and style, not a generic layout.
Drafts from your past projects and SOPs, with sources shown.
Every step linked to its requirement as it is drafted.
IQ/OQ/PQ, FAT/SAT, test specs, compliance answers, justifications.
The Verifier Agent re-checks every draft first.
Word and PDF, ready for your document system.
Every output links back to its sources and waits for a person to sign.
| Manual / consultants | Generic AI (ChatGPT, Copilot) | Qualitum Drafting 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 agentFinds missing, partial and conflicting evidence before the auditor does.
Meet the agentRe-checks every draft against its source with multi-model consensus.
Meet the agentKeeps a live trace graph and flags everything a change touches.
Meet the agentNo. It drafts from your requirements, past projects, SOPs and templates, and shows which source each section came from.
Yes. Drafts are editable in Word or in Qualitum. Every edit is recorded.
Inside a Global Top-10 pharmaceutical manufacturer, authoring time on IQ/OQ/PQ fell by 70%.
Yours. It learns your template structure and numbering from examples you provide.
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.