This e-document is presented in the form of a generic template for use in developing a validation master plan (VMP). VMPs assist in scheduling of project activities for process validation; help management understand what validation activities will require in respect to time, staffing, finances, etc.; enlighten the validation team on their tasks and responsibilities; and specify for the auditors the validation approach employed and the organization of the validation activities.
The e-document is purposefully concise to enable fast reference by engineers and other professionals involved in validation activities for medical devices. It uses specific and detailed illustrations to facilitate grasping of the concepts and populating of the VMPs for processes, production lines or value streams.
The e-document is purposefully concise to enable fast reference by engineers and other professionals involved in validation activities for medical devices. It uses specific and detailed illustrations to facilitate grasping of the concepts and populating of the VMPs for processes, production lines or value streams.
