Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.
Furthermore, FDA expects general validation processes to include details on who should perform and approve the validation study, what standards are acceptable, and when revalidation is needed. FDA also requires companies to conduct these validation tests in accordance with established procedures and to record the outcomes of their studies.