Fine-Tuned LLM Drafting Assistant for a Device Manufacturer's Quality Documentation
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Problem
Slow hand-written quality documents
A medical-device manufacturer with 10 production facilities had engineers drafting SOPs, CAPA reports and change-control documents entirely by hand. Formats drifted between facilities, first drafts took most of a working day, and internal audits repeatedly flagged inconsistent structure and missing template sections, dragging review cycles out across multiple rounds of correction.
Solution
Fine-tuned drafting assistant
We fine-tuned a self-hosted open-weight LLM on the manufacturer's corpus of approved quality documents and paired it with retrieval over current QMS templates and procedures. The drafting assistant sits inside the existing document workflow, generating structured first drafts that engineers edit and route through the unchanged review and approval chain — no document is ever released without human sign-off.
Measurable Impact
What changed after launch
First-draft time for CAPA reports cut from roughly 6 hours to under 2
Template-conformance findings in internal audits down 63% over two audit cycles
Average review rounds per document reduced from 3.4 to 1.8
All 10 facilities onboarded to the assistant within 4 months
Tech & Tools Used
What powered the build
Ready to Build your Life Sciences & Med Devices Business with LLM Integration & Fine-Tuning
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