- It is defined here: Section 4.1.6 of ISO 13485:2016
- You are asked to do a very commonsensical thing:
Validate the software that you are using related to Quality Management activities, making sure that activities are proportionate to risks taken.
You need three documents:
- A list of computer software in which you keep track of all software you’re using at your company. [...]
- A template for a validation plan which you’ll need to fill out for every software on that list. [...]
- A template for a validation report which you’ll also fill out for every software on that list, unless you determine that you don’t need to test it. [...]
List of computer software: That's easy.
Validation Plan: This is a list with dates where you performed software validations
Validation Report: Kind of a report stating what you exactly did to validate the software you're using. Dr Eidel suggests the following criteria are described:
- Software Identification
- Intended Use
- QM Relevance
- Risk Analysis
- Validation Procedure (Test approach/ procedure)
Once you are doing this for every software used, you are safe.
Thanks to Dr Oliver Eidel who laid it all out in a beautiful an simple way here:
PS: Of course, relatico can be used in a MedTech or ISO 13485 environment.
Please contact us to find out more.