Clinical-Stage Biotech Company Accelerates GxP System Validation

The Challenge

At the clinical stage of drug development, every minute counts. This life sciences company selected Microsoft Dynamics 365 for Finance and Operations (D365) as its Enterprise Resource Planning (ERP) system, and the nature of its business made ERP system validation mandatory.

Company executives wanted the foundation for automation in place early, so automated processes would be ready when the company was fully commercial with products on the market. They also needed to achieve 21 CFR Part 11 compliance. While a system integrator implemented D365, the company chose OnShore Technology Group to provide independent validation and verification (IV&V) services and deliver a turnkey validated ERP system within budget.

The Solution

OnShore Technology Group delivered a three-part solution while the system integrator implemented the ERP system:

• CloudMaster 365^™ for D365: An Enterprise Validation Accelerator built for Microsoft Dynamics 365, with out-of-the-box requirements and a starter set of IQ/OQ/PQ test scripts that reduced document preparation and testing time.
• ValidationPro^℠ Enterprise Validation Delivery Services^™: An experienced, ready-to-work validation team that prepared all validation deliverables, updated and developed test cases for the client’s technical and functional requirements, and managed the project from end to end.
• ValidationMaster^® platform: Deployed out of the box with no additional cost for validation, automating IQ/OQ/PQ and User Acceptance Testing.

The team also helped develop Standard Operating Procedures for ERP system and validation process governance, which are now fully automated.

The Results

• On time and within budget: The client went live with its D365 ERP system as planned.
• 60% reduction in test preparation: CloudMaster 365^™ delivered many of the required test scripts out of the box, so the client only needed new scripts for customizations.
• Reusable test script library: Scripts stored in ValidationMaster^® help the client maintain the validated state through subsequent D365 releases.

The client established the automation that sets the foundation for future validation success and has re-engaged OnShore Technology Group to help keep the system in a validated state.