Background

A medical device manufacturer developed custom automation equipment to assemble and weld medical-grade check valves, incorporating a PLC, HMI, vision system, and ultrasonic welder. During an ISO audit, it was discovered that the software controlling the automated assembly equipment had not been validated. Compounding the issue, newly built equipment—critical to meeting urgent production demands—also required validation, but the client lacked the necessary in-house software validation expertise.

Regulatory Compliance Associates® Inc. (RCA) was engaged to develop comprehensive validation documentation and deliver expert validation services. RCA ensured the software met regulatory requirements and that the valve assembly system was fully validated and ready for production—all within an aggressive timeline.

RCA Approach

RCA integrated software validation as a core component of the overall equipment validation process. Following GAMP 5 guidelines, a risk assessment was conducted to identify user and functional requirements that posed the highest risk to product quality and patient safety. These high-risk functions were subjected to the most rigorous testing to ensure the automation equipment consistently assembled components in compliance with critical product specifications. This risk-based approach not only ensured a robust and compliant validation but also significantly reduced the overall project timeline.

Result

The validation was successfully completed within the aggressive timeline, with efforts strategically focused on equipment functions that posed the highest risk to product quality and patient safety. As a result, the client received a dependable, risk-based validation, and the new equipment was ready for production by the project’s target date.