Software validation procedure

Software validation procedure described in 4.1.6 applies to any computer software used in the quality management system. But, if a medical device is a software or software is a part of the medical device, then it is covered with another standard (ISO 62304). 

This software validation is not validation that IT companies who produce software make before releasing the software. Software validation according to the ISO 13485:2016 means that you need to be sure that any change in the software (solving bugs or adding new features) won't change your data and your process. 

Validation is necessary only when you install some software for the first time, or when something changes. You need to have a system in place how you will receive the information from the IT company about any changes in the software that you use and what will you do whit that changes . 

Specific approach and activities associated with software validation are proportionate to the risk associated with the use of the software. So, it is up to your Top management which software you will consider validating. Usually, it is any software used in the production (software that is on some machine used in the production), software used for warehouse management, making delivery notes, purchasing, then if you use any kind of maintenance software and calibration software. 

You can find the example od the Record of Software Validation here: https://advisera.com/13485academy/documentation/record-of-software-validation-iso-13485-2016/

This is helpful, and I would be interested in hearing more about this in one of your webinars, perhaps? Many thanks.