Case Studies

Pfizer:

Reduced open complaints from 7,000+ to under 4,500 in 6 months — enabling compliance with a key performance target.

Olympus:

Developed verification checklists for global complaint records and improved timeliness of MDR reporting. Supported 3rd Party suppliers in the EU with compliance to company global operating standards.

ACell:

Led CAPA/NCR process redesign; improved closure timelines by 40%. Achieved zero findings in ISO 13485 recert audit in 2019.