Process validation in the medical device industry plays a crucial role in ensuring a successful and effective manufacturing flow. The various challenges associated with process validation can be demanding and often require innovative, out-of-the-box solutions. Gsap, in collaboration with Flex, has joined forces to address the most common challenges in the process validation (PV) process. To contribute to the successful completion of PV, we hope to impart to our community our vast professional knowledge and practical expertise.