Background A $4 billion generic pharmaceutical company recently acquired an Eastern European pharmaceutical company. The business plan for this newly acquired business unit is to aggressively expand sales into European Union markets.
Business Issue Executive management recognized that a new ERP system needed to be deployed at this acquired site to support the anticipated increase in business volume and complex supply chain model. Moreover, the corporation mandated that this system be validated to meet U.S. and E.U. regulatory requirements currently followed at other company locations.
The Objective Implement a validated ERP system to meet regulatory approval.
The Solution Arbour Group deployed consulting resources from its Dublin, Ireland and Dubai, United Arab Emirates offices for this project to work on site with senior management and the project team leaders to validate the enterprise system. Working aside the implementation team, Arbour Group successfully validated the software system. 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 was the first computer validation effort for this site. Arbour Group worked closely with client personnel to train and mentor local resources throughout the project.