They had 30 days to check 500+ procedures against GMP. They finished in 1 week.
A medical device manufacturer had to check every procedure against GMP requirements within 30 days. With AI, its own team reviewed 500+ procedures and found 200+ gaps in 1 week, with no added consulting fee.
Medical device manufacturing · 100+ people · operations on 3 continents · 12 departments · 500+ procedures
Does this sound like your company?
These are the pressures the gap analysis had to handle. Many regulated manufacturers face the same ones.
- Hundreds of procedures, spread across every department, and nobody could say which ones still met the regulation.500+procedures across 12 departments
- Regulatory deadlines don't move, whatever your workload.30 daysto check every procedure against GMP requirements
- The gaps were real, and there were many of them.200+gaps between procedures and the regulation
Each gap was a finding waiting for an inspector. Now each one has the regulation section next to it and the wording to fix it.
The same project, with and without AI
| Without AI | With AI | |
|---|---|---|
| Time for the gap analysis | 30-day deadline | 1 week |
| Who did the work | External consultant, added to the contract | The company's own team, during working hours |
| Added consulting fee | Yes | None |
| Time to write and review a new SOP | 1 week | 1 hour |
How it worked
Read
The team chose the regulation and the scope. AI read the 500+ procedures and the GMP requirements.
Map
AI matched each procedure to the regulation sections, flagged the gaps and drafted the compliance wording. A reviewer and an approver from each department checked the results.
Act
Department experts worked through the 200+ gaps. The team now updates procedures with AI, and new SOPs take 1 hour to write and review. People approve every change.
AI handled the volume. The scope, the reviews and every approval stayed with people.
Big, complex work. Done in a fraction of the time.
Bello & Bel helps companies take on complex tasks with the support of AI, so your team delivers in weeks what used to take months.
- AI Readiness Assessment: where you stand and what to do first
- Tailor-made AI tools that remove the manual work