Verification & Validation - Your Ideas Consulting

Go to content

Main menu

Verification & Validation

Process Development

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-model:

  • Product layer

  • system layer

  • Component layer

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).

A bottom-up reporting of all V&V activities executed,
should be documented in a respective master validation summary report document (the document may utilize sub reports for reporting), including pass/ fail indicators provided and deviations described.

Back to content | Back to main menu