Medical Device Traceability Matrix

Description
s_g_robertson
Posts: 3
Joined: Wed Aug 03, 2016 9:50 am

Medical Device Traceability Matrix

Postby s_g_robertson » Tue Mar 28, 2017 2:25 pm

I'm wanting to produce a traceability table (Medical Devices development) that shows the relationships I've tried to express below. There is no problem creating the links and navigating through them inside Polarion but what I want to produce is an output (pdf/excel/word/...) showing a matrix.

User Requirement > Validation Test Case & Validation Test Result > Product Requirement > Verification > Test Case & Test Result

Where:
Each user requirement must map to
-at least one validation test case and result
-at least one Product Requirement

Each Product requirement
-may, but does not have to map to a User Requirement
-must map to at least one verification test case and result

So the largest set of results will be the product requirements. I can fairly easily get the information split across three outputs using the ExtensibleTraceabilityTable extension.

1.User Requirement > Validation Test Case & Validation Test Result
2.User Requirement > Product Requirement
3.Product Requirement > Verification > Test Case & Test

but my problem is because not all product requirements are mapped to from a user requirement. It feels like I really need to start in the middle and work out in both directions, but I have no idea where to start.

Any suggestions?
Thanks
Stephen

Phoebe
Posts: 2
Joined: Wed Apr 12, 2017 8:46 am

Re: Medical Device Traceability Matrix

Postby Phoebe » Wed Apr 12, 2017 9:10 am

Hi Stephen,

we are using a custom Wiki page to generate traceability matrices. The algorithm is the following:
1. Query all Product Requirements
2. For each Product Requirement, query linked User Requirement and Verification
3. For each linked User Requirement, query linked Validation
4. For each Verification, query linked Test Result
5. Plot Table row containing the current Product Requirement along with its User Requirement(s), Verification etc.
6. Repeat 2.-5. for every Product Requirement
=> This table is used for documentation.

Additionally, we use a list of "Unlinked User Requirements" to check whether there are any User Requirements that have not been mapped to a product requirement yet.

Regards,
Phoebe

s_g_robertson
Posts: 3
Joined: Wed Aug 03, 2016 9:50 am

Re: Medical Device Traceability Matrix

Postby s_g_robertson » Fri Oct 06, 2017 2:35 pm

Hi Phoebe,

I completely missed your reply.
That is exactly what I would like to be able to do. Is your wiki page based on something that is publicly available or did you start from scratch?

Thanks
Stephen


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