The responsibility for validation lies with the regulated company.
It must establish guidelines and procedures for the validation which fulfill the legal requirements. Good Automated Manufacturing Practice (GAMP) serves here as a globally recognized code of practice for validation. It describes the tasks and duties of the supplier and the end user, together with the validation process.
A significant element of validation is the technical inspection of individual systems and devices.This section is designated Qualification.
The regulated undertaking must check whether the Zwick testing systems used in the medical engineering and pharmaceutical industries are subject to the legal requirements so that qualification is necessary. The operator of the system is required to maintain the valid status of the system throughout its lifetime.