Pulse Oximetry Device Manufacturer Restores the Validated State on a New Cloud ERP

The Challenge

This highly regulated medical device maker was moving from its legacy ERP system to the latest cloud version, and time was of the essence. The current system was in a non-validated state and past its extended support window. The project included data migration to the new environment, customized functionality, and seven third-party integrations.

The company’s validation program was manual and paper-based, it had no Standard Operating Procedures in place, and validation resources were limited. Its goals were to improve supply chain processes and increase automation for validation and other quality processes, so it engaged OnShore Technology Group to deliver a turnkey validated ERP system within budget.

The Solution

While the client’s system integrator implemented the ERP system, OnShore Technology Group delivered a three-part solution:

• CloudMaster 365^™ for D365: An Enterprise Validation Accelerator that provided out-of-the-box requirements and a starter set of IQ/OQ/PQ test scripts.
• ValidationPro^℠ Enterprise Validation Delivery Services^™: A ready-to-work validation team that prepared all deliverables, developed new test cases, supported the upgrade and migration, and managed the project from end to end.
• ValidationMaster^® platform: Deployed out of the box at no additional cost, simplifying IQ/OQ/PQ testing and User Acceptance Testing.

OnShore Technology Group also developed the SOPs that govern the ERP system and its automated validation processes.

The Results

• Validated state restored: The new ERP system was implemented and validated on time and within budget.
• 60% reduction in test preparation: CloudMaster 365^™ delivered many required test scripts out of the box, so only customizations needed new scripts.
• Reusable test scripts: A client-accessible library minimizes time and effort for later validation work.

Today the client uses ValidationMaster^® for all of its validation program needs, including equipment, process, and computer system validation for other applications.