Background A Fortune 100 pharmaceutical company divested its infant formula division. Under local management ownership, the new company was required to deploy a new ERP system to replace the legacy corporate system.
Business Issue The new company selected a major enterprise software package for its manufacturing, distribution and financial system. Management was under a tight deadline to implement this ERP system because of signed divestiture agreements made with the former parent company. The strict regulatory environment on infant nutritional products made it imperative that this system be validated and that it comply with FDA-enforced regulations, including Part 11 Electronic Records & Electronic Signatures.
The Objective Implement and deploy a validated ERP system within 5 months.
The Solution Arbour Group worked closely with senior management and the project team leaders to validate the enterprise software prior to its deployment in production. Following the implementation model (project preparation, business blueprint, realization, final preparation), Arbour Group successfully validated the software system. Validation deliverables consisted of:
- Validation Plan
- User Requirements
- Functional Specifications
- Platform IQOQ Protocol
- Application IQOQ Protocol
- System PQ Protocol
- Validation Trace Matrix
- Validation Summary Report
Arbour Group engaged effectively with the implementation team and worked to minimize the impact on exiting project resources. Specifications for the GMP functions were defined utilizing the business blueprint documentation. Validation test documentation was developed utilizing Arbour Group's test libraries along with business process procedures developed by the implementation team.