Yes, you need to validate all tools you use for production and service provision of medical devices and the quality management system, specifically also tools for your documentation.
But don't worry we don't let you alone. There are two scenarios which need slightly different validation:
- MatrixALM and/or MatrixQMS in the cloud
- MatrixALM and/or MatrixQMS running on your own servers
In both cases we will support you so that you don't need to spend a lot of time redoing what we did already: you can have our own validation and verification documents, which cover the normal usage in the cloud.
If you use the cloud version, the only thing you should do is
- to verify that Matrix is configured according to your needs, e.g.
- risks are configured as you specified in your procedures
- traceability is set up as you need it
- tests are configured correctly
- that you have our validation documentation for the correct version
If you installed Matrix on your own server you not only need to verify the configuration (see above) but also
- are backups of the system configured correctly (operating system, file storage, database)
- is the basic functionality working (e.g. access, database changes, file storage, document generation, ...)
- do you have enough data storage for file attachments
We suggest that you validate Matrix and other tools using a special Matrix project setup with a simple traceability between requirements, risks and tests.
We provide you with some common requirements, risks, and tests cases for validation Matrix software in the TOOLS project available in your instance.
Note: interesting blog regarding validation: https://matrixreq.com/blog/What_is_required_for_validation_of_software_used_in_QMS_processes_.html
Look at the recorded webinar on Software Validation with our TOOLS Validation project: (direct link here)