The new 2016 version of ISO 13485 on the quality system for the production of medical devices has increased the emphasis on the need to validate the software systems used in the medical device quality management system. It is therefore a question of software used for example in production, therefore not included in a medical device, to which more stringent requirements apply.
The guidelines available for these activities are version 5 of the GAMP (from 2008). This proposes the basic concepts of the software life cycle, the software categories and the risk analysis to plan and execute the systems validation activities, as required by the GMPs.
These guidelines are widely used by the pharmaceutical industry, but they are applicable with the due common sense (or if you want critical thinking).
To deepen the fundamental concepts of validation such as the software life cycle, the software (and hardware) and Risk Analysis categories, download the PDF document (ITA).
