Industry: Pharmaceuticals
Background The corporation was operating numerous manufacturing, distribution, and sales operations throughout the world.
Business Issue A patchwork of business systems was preventing a faster penetration of new markets and was constraining profitability.
The Objective Establish a corporate computer system quality policy and related procedures to ensure validation and compliance across the corporation.
The Solution The corporate-driven ERP implementation centered on establishing a standard ERP configuration for the corporation. This configuration would then be rolled out to each site. Arbour Group was responsible for assisting with validating this system at each site. Working with the client's worldwide implementation team, Arbour Group first developed a validation package for the client's standard ERP package configuration. This package included:
- Validation Plan
- User Requirements Specification
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requirements Traceability Matrix
- Validation Summary Report
Each site received a CD containing this validation package. As the ERP system was rolled out at each site, Arbour Group performed validation training for site personnel. These sessions were comprised of both GMP awareness training and detailed computer validation training. In reviewing the baseline validation package, each site was instructed to perform additional hardware validation testing for locally developed reports and configuration changes. Arbour Group provided follow-up technical assistance to support each site with validation.