October 25, 2012

Webinar Recording: Gaining More than FDA Compliance Through Traceability

Helix ALM
Requirements Management
Thank you to everyone who participated in the Gaining More than FDA Compliance Through Traceability webinar. The recording is now available if you weren’t able to attend or if you would like to watch it again. http://youtu.be/TABhQ_thgB0 If you'd like to buy Dave's book, browse to www.ArtechHouse.com/vogel and use promo code DV25.

Q&A

Q: When generating a requirements spec does the tool output all the requirements in a format that is easily incorporated into a document, such as a Word document, that can be formally released as a controlled document? A: Yes, you can export to Microsoft Word. You can then release the Word doc as a controlled document. Q: What data do you have to support claims of reduced cost from more timely reports and higher accuracy? A: We don't have specific data use most people do not measure it. Q: Can you please share a real-life example of out-of-control regression suites? A: When a company decides to rerun every test in the test collection for every iteration of the software—I would call that out of control. Q: If my company wants to use Excel to create traceability, will the FDA see this as a controlled document? A: I think some people argue that you can use Excel if you have it under document controls, but clearly we are trying to create efficiencies.