COTS Validation

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.).

Thanks, Sergei!



As usual, SmartBear/AutomatedQA has come through on the service side of things.  I've forwarded your comments to our portfolio manager who is in charge of our validation efforts to see if a joint venture is something we want to do.  I'll get back to you as soon as I know more.



Again, thanks a lot for the input!

Sergei,



I've been in conversation with our folks here and there is a definite interest in a partnership in this validation effort.



Please contact me as per my e-mail address: rmartin at epharmasolutions dot com and we can start these conversations.

robert Martin [TeamAQA]                   

However, if anyone has any particular insights of things to test, things to look at, areas to cover, etc., for this kind of validation, I'd love to hear from you.  Essentially:

 

When I've done COTS validation for FDA projects, I've focused on the the features of the products that we've used in our testing.  This is covered in the Special Considerations section of 21 CFR Part 11 (section 6.1.3 specifically).



@Sergei Sokolov

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.

After this effort has been completed, is it intended that the end result (self executing test suite, supporting documentation, etc...) would be available to other customers? 

russell



Thanks!  That actually coincides a good bit with what we've started drafting out.  Rather than validating EVERYTHING, we're validating those parts that we intend on using.

Hi!

We're starting the process to validate the tool for the FDA and I found this post when I searched info about the 3er party tools validation (one of this tools is TestComplete).



You can help me to do the correct way with any tips about these validations?



You've some requirements or cases lists used to validate the tool?



Any help is welcome! :D



Thanks in advance!!!



Miguel

Miguel

tool validations are typically driven by internal company standards and the internal test and validation workflow. I have worked with a number of customers in my past life who were doing business in regulated industries, so I am well familiar with the general principles.



Typically, what you'd need to do is establish what it is that you need to validate regarding the tool, and this in most cases amounts to proving for the right folks in your organization who are responsible for this, that the tool actually does what it is supposed to do.

You can rely on your internal validations, or vendor statement of some sort that certain feature areas are covered by vendor's own manual and regression testing, or a combination. There is really no guideline regarding what you actually need to validate.



We can help you with additional information as you go through the process.