At the beginning of a validation project the basic approach for the validation of the target system will be determined.

With knowledge and experience it is possible, even in the early stages of planning, to make use of possible freedom in the laws and regulations. A well-selected validation strategy provides an opportunity at the very beginning to avoid unnecessary future expenses.

Starting from early discussions, the level of detail appropriate for “requirements” and “technical” texts can be determined, and documents delivered by manufacturers or suppliers can be integrated. A good selection of an adequate level of detail can help reducing later work.