Enterprise Quality Management Systems (eQMS) are a mature technology foundation. The architecture of these systems vary from vendor to vendor. The validation of these systems is a constant. Most software vendors provide a stack of validation documentation for these systems that require some knowledge of the basic operation of the system while others will validate the system for you.
In the "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", issued on January 11, 2002, the FDA states "...If the vendor can provide information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer can use that information as a beginning point for their required validation documentation..."
THE BEGINNING OF VALIDATION
The Validation Accelerator is the beginning of the validation for your Quality Management System. The Validation Accelerator provides all of the system requirements, validation test documentation coupled with an automated, ready-to-use Enterprise Validation Management system to drive your lean validation process.