COTS Validation
Rarely do I ask questions so you know this one is a doozy... I've been using TestComplete for almost 10 years now in various kinds of tests and such so I don't have any real problems with the a...
Forum Discussion
Robert
we will be happy to work with you to facilitate your putting together the validation package.
As you understand the package could be done entirely by the end user, or partially provided by the vendor.
What I propose is that we identify the necessary test scope that your organization would find necessary to meet your tool qualification criteria, and then we could jointly work on making this available.
Considering the framework offered by TestComplete and TestExecute, it should be possible to provide (at a later stage) a self-testing package that is run against TestComplete.
There is a self-referential challenge here, however. If we rely on TestComplete to test TestComplete (as we do in our regression tests in house, across versions) FDA may not necessarily like it or consider appropriate.
We want to visibly expand with the TestComplete offering into the regulated industries in the next year or so, thus working with you on this project will be extremely valuable to us as well.
As a footnote, I am well familiar with 62304 and GPSV documents, but not as much with the tool qualification process (even though I understand what it's for etc.).
we will be happy to work with you to facilitate your putting together the validation package.
As you understand the package could be done entirely by the end user, or partially provided by the vendor.
What I propose is that we identify the necessary test scope that your organization would find necessary to meet your tool qualification criteria, and then we could jointly work on making this available.
Considering the framework offered by TestComplete and TestExecute, it should be possible to provide (at a later stage) a self-testing package that is run against TestComplete.
There is a self-referential challenge here, however. If we rely on TestComplete to test TestComplete (as we do in our regression tests in house, across versions) FDA may not necessarily like it or consider appropriate.
We want to visibly expand with the TestComplete offering into the regulated industries in the next year or so, thus working with you on this project will be extremely valuable to us as well.
As a footnote, I am well familiar with 62304 and GPSV documents, but not as much with the tool qualification process (even though I understand what it's for etc.).