First off. Happy New Year! Second, I wanted to share some news for all you folks who follow goBalto’s comings and goings. We’ve successfully completed our FDA 21 CFR Part 11 compliance audit for Tracker! Why is this important? Clinical trial sponsors and sites that run clinical trials must adhere to strict FDA rules and regulations. They expect that all the tools and platforms used in a trial are compliant with these rules.
goBalto uses Agile software methodologies to develop Tracker; this allows us to quickly evolve Tracker in response to customer feedback. (think releases in terms of months versus the traditional annual release by the vast majority of on-premise enterprise software solutions.) goBalto and David Nettleton (CFR Part-11 compliance consultant) found innovative ways to balance 21CFR Part 11 compliance requirements with cutting-edge Agile practices.
Personal thanks to David, our QA team and legion of testers who were able to make this happen before the year end!
If you’re a clinical trial sponsor or contract research organization interested in seeing the compliance letter, please send an email to phu@gobalto.com.
