The Problem
Global medical technology and sterile medical device manufacturer needed unified document workflow automation, strict revision control for technical drawings and sterilization batch records, and automated calibration for cleanroom equipment. Superseded revisions risked being accessed on the shop floor.
The Implementation
Integrated DoxCraft for centralized document control, automated change notifications, and SOP versioning, paired with PrecisionCAL for cleanroom autoclave and testing apparatus calibration.
The Outcomes
- 100% revision control compliance eliminating obsolete drawings and SOPs from shop floors
- Testing certificate and technical document retrieval time slashed by 90%
- Flawless ISO 13485 (Medical Devices) and GMP compliance audits
- 50% faster change-control approvals across cross-functional engineering teams
- Role-based access security ensuring confidential device schematics remain protected
"In medical device manufacturing, strict batch traceability is mandatory. Micraft digitized our standard operating procedures, ensuring continuous ISO 13485 readiness."
— Regulatory Affairs & Quality Lead, B. Braun Medical
