Requirements Traceability Database - Have one? Help create one?

W

wwcanoer

I am setting up a new QMS system for a start-up and would like to track what documents are used to comply with various standards requirements & guidances (ISO13485, GHTF, QSR, etc.). (RTM, Requirements Trace Matrix)

My ideal system:
Import the requirements text of each standard and guidance. For each requirement, list the documents that address that requirement. Then be able to easily answer the following questions:
1) What documents address requirement yyyy?
2) What are all of the requirements that the xxx document must address? (providing a list of the text of every requirement. ISO, GHTF, QSR, etc…)

Choices:
- Excel is cumbersome for these many to many relationships that are better suited to a database.
- All of the requirements software that I looked at have a zillion entries for each requirement and each use case or test but I don’t need 90% of it. (I only looked at a handful of the zillion programs that are out there but did not see any promising leads for a light free one.)
- I could create an MS access database (but it has been 8 years since my last db, so it is not as simple as I thought)
- I quickly checked for free online databases (very few out there) but the ones I looked at don’t allow import from a file (i.e. the standards text). There are free dbs for placing dbs in websites but looked like more of a learning curve than using the MS access that I know (though it has been a while).

Question:
Does anyone have a database (or other system) that they could share or recommend? Anyone want to help create an MS Access database for this?

Discussion:
I have found various gap analysis and checklists as MS Word tables or spreadsheets but then I cannot easily link the text note/response to the actual document or doc status.
 

Ninja

Looking for Reality
Trusted Information Resource
Question:
Does anyone have a database (or other system) that they could share or recommend? Anyone want to help create an MS Access database for this?

I would jump in and say "Sure, I will" but there would be a fee involved and I'm in the US...and I would be using Filemaker Pro instead of Access.

The hardest part of building a customized Dbase (as you probably already know) is deciding what you want the Dbase to do for your specific needs...that's why most Dbases for this do just about everything...that makes them more acceptable to the general market.

If I may suggest, decide pretty thoroughly want you want it to do, and how you will mine the data later, then check out Access programmers in Switzerland and farm the job out. If you already have decided the main functions, the cost should not be all that high. Us Dbase builders spend most of our time helping the customer/company decide what they want...the build doesn't take all that long if the target is already well established (and doesn't get revamped halfway through the build process).

JMO...
 
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