The TOOLS project is created to give you a project where you can centralize all your validations of the different software tools you are using (Matrix software and/or other software).
It allows you to:
- define the requirements for the tool
- define risks related to it
- define test cases you want to do in order to validate the tool
- execute the test cases and document the results
For MatrixALM and MatrixQMS there are already some pre-defined test cases that you can execute in order to document your validation of our software.
In this TOOLS project, you’ll find:
- our release documentation in FILE category (Our validation report, our release note, our ISO 13485 and ISO 27001 certificates,..)
- a description of the applications in the TOOL category
- some Requirements describing our applications in REQ,
- some Risks defined
- and a category with Test Cases.
- You'll also find the Validation Plan and report documents, ready to be signed in the "Documents Tab"
The only thing to do on your side to validate the usage of our software is to execute the prepared TCs (and to sign the prepared documentation as well available in the Documents Tab of that project). If needed, some extra Requirements, Risks or Test cases can be added.
An advantage of the TOOLS project is that you can reuse the project to structure and do the validation of any other software you’re using to build your medical device.
Moreover, in the upgrade process, we let you choose when you would like to be upgraded, it’s not automatic so that, if you’re in the middle of an audit, you can keep the older version a few more weeks for example.
So, everything is set up for an easy self-validation.
In order to go through the tests, you need to execute them: Executing Tests
The results can be documented in either a test report or a document: see Controlled Documents
Look at the recorded webinar on Software Validation with our TOOLS Validation project: (direct link here)