Case Study: Vascutek (a Terumo Company) achieves compliance and cost savings with MasterControl

Efficiency Helps Vascutek Maintain Compliance Whilst Saving Money

Vascutek, a Terumo company and global leader in vascular and cardiovascular devices based in Inchinnan, Scotland (with a valve facility in Leeds), faced a growing compliance challenge: thousands of controlled documents and paper-based processes that were slow, error-prone and costly to manage while meeting FDA, ISO 13485 and ISO 9001 requirements. Manual sign-offs, hard-to-track change notes and time wasted chasing documents threatened efficiency and regulatory readiness.

Vascutek implemented MasterControl (Documents and Process, with Training to follow), going live in February 2010 after consultant-led demos, internal training and a validated IQ/TOQ/PQ approach. Role-based access drove fast user adoption; change requests and reviews became trackable and electronic. The result: substantial time and resource savings (less paper, folders and storage), smoother external audits, improved process ownership and a clear return on investment.

Vascutek

Gayle Baillie

Senior Quality Control Associate