Validation Approaches, Tools, And Services

Validation is a documented process that demonstrates that a system was developed, implemented, operated, and maintained in a controlled manner. This process provides assurance that the system consistently meets specifications and is suitable for intended business use.

Process Validation
ANSI/IEEE defines validation as “the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.” 

The Food and Drug Administration (FDA) defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” 

The EMA Draft Guideline defines process validation as “the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.”