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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.
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.