We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted ...

Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...

Even with technology changing faster than validation procedures can be rewritten, it still is possible to perform thorough product testing. With the ever-changing complexity of automotive electronics ...

This paper briefly discusses the approaches for Validation Environment and Test methodologies adopted for 8-bit microcontroller family based products. We would be focusing on modularity and the need ...