Industry: Medical Devices
Service: Quality Assurance
Background The company had experienced rapid growth in recent years. This growth required the manufacturer to significantly expand its facilities and substantially improve its business systems to support this increased level of business.
Business Issue Senior management anticipated increased regulatory scrutiny associated with these new product approvals and the expansion in manufacturing capability.
The Objective Implement a scalable ERP system in compliance with QSR regulations.
The Solution Arbour Group deployed its consulting resources that worked in conjunction with the implementation partner to design regulatory grade business practices to support its growth. These practices were manifested in the application configuration and successfully validated. Validation deliverables consisted of:
- Validation Plan
- User Requirements
- Product/Patient Safety Risk Assessment
- Functional Specifications
- Platform IQOQ Protocol
- Application IQOQ Protocol
- System PQ Protocol
- Validation Trace Matrix
- Validation Summary Report
This project allowed the company to lower its regulatory risk, and avoid any costly interruption in business, all the while continuing its torrid expansion.