ABSTRACT
This chapter addresses validation from the perspective of defining and capturing all of the elements associated with the validation process in developing a Master Plan. It describes a method that is applicable to any validation, whether it is a process validation associated with sterilization or a software validation associated with a product. Validation in the medical device environment has taken on new meaning in light of the many existing regulations and the pending changes to the current Good Manufacturing Practices. The key to any validation plan is the early recognition by all concerned parties that this is a regulatory requirement and that the product development timeline must take the validation process into account. Given the importance of validation, the Master Plan should be considered as a controlled document approved by all participants. The Master Plan identifies the subordinate and related documents needed to accomplish the goals of the protocol.
