Background A global pharmaceutical manufacturer planned to expand the distribution of a key product to 40+ countries throughout the world. The management of production and distribution process was being performed using non-integrated manual processes.
Business Issue Product growth required a cost effective software solution that automated supply chain functions and implemented in a tight time frame with minimal infrastructure requirements.
The Objective Implement a cloud-based ERP software system that meets the requirements of regulatory agencies to include the U.S. Food and Drug Administration (FDA), Irish Health Products Regulatory Authority (HPRA) and European Medicines Agency (EMA).
The Solution Arbour Group ensured the compliance for this SaaS software through (1) audit of the software developer/host provider to ensure adequate controls were in place for development, release and change control as well as data center security and operational controls (2) testing the remote third-party platform for proper installation, security and access controls, (3) validating the software for its intended uses and (4) implementing the procedures and controls necessary to assure an ongoing state of compliance. The validation deliverables included:
- Validation Plan
- User Requirements/Functional Specifications
- Platform Installation Qualification (IQ)
- Application Operational Qualification (OQ)
- System Performance Qualification (PQ)
- Requirements Trace Matrix
- Validation Summary Report
- Vendor Audit Report
- Standard Operating Procedures