What is the exact meaning of validate and initial? and [how] what should the prime supplier do to realize validation and iniallization?
..Validation " an approval according to objective evidences that the requirements for the product intended use are fulfilled.
Revalidation " a re-approval of validation in case there any changes occurred within the process, a change of equipment, a change in human resources, raw material " anything that may affect the product.
Got it. It is indeed a combined standard.
Thank you all!