Regulatory Documentation & Submissions
The Challenge:
A medical device company preparing regulatory submissions for new products manually compiled documentation from 15+ systems, taking 3-4 weeks per submission with frequent rework due to missing or outdated documents. This delayed time-to-market by months.
The Solution:
Implemented Power Automate workflows pulling documentation from engineering, testing, quality, and manufacturing systems into Fabric. Azure AI validated completeness against regulatory requirements. Power Apps provided submission tracking and stakeholder collaboration.
Result:
Submission package preparation time reduced from 4 weeks to 3 days, document completeness improved to 99.2%, and accelerated time-to-market by 8 weeks per product, generating $4.2M additional revenue annually.