Verification and Validation Process
The verification and validation process is starting during the realization phase in a defined and controlled integration process accompanied by test activities, beginning on module level and ending in a fully functional product (to be validated in customer environment).
The structure of the verification and validation activities is defined by a layer based V-
Each activity has a different focus, variables and test environment (see below).
A plan breakdown of all V&V activities for a product (platform & assays) with its components including manufacturing should be documented in a respective master validation plan document (the document may link into sub plans).