Facilities Validation Master Plan

Each Validation Master Plan (VMP) must outline the following: principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. A VMP is a document that details the way a company will operate, who has control over the various aspects of the validation activities, and how production, quality control, and personnel management will be directed. Ideally, from a risk perspective, the VMP should include an overall assessment of the potential impact of the R&D processes on the quality of the new product. When you use a risk-based approach, then VMP will identify which processes to validate and in what order to perform the validations.

By performing validation, an organization can make sure that the processes can produce the planned results consistently.

For more on how to perform validation, please read the following article: 

Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/