With the help of a large and passionate community, Dean Leffingwell and I feel confident in answering yes to the question we posed last December, “Is Agile the key to building high assurance software?” Based on the feedback we’ve received in Dean’s Scaling Software Agility Blog and the large number of medical device companies already successfully utilizing Agile practices, it’s clear that Agile is vital to bringing highly innovative and high assurance products to market before your competitors. Here are a some of the comments we’ve received from practitioners.
“I think this is quite interesting, and quite possibly could revolutionize the way medical device software is delivered. Life sciences is the last bastion of waterfall development methodology. I look forward to championing the cause!” - Bernie Barbour
“Having been in FDA regulated development environments for over 10 years, this truly is an area where most people live & breath waterfall. But as you said, there are a few out there already doing agile in this domain and I would argue that it can be done (relatively) easy.” – Michael Meissner
The community really stepped up to help us pave the way for developing the first guidance truly focused on the details of implementing Agile in High Assurance Environments using Medical Devices as are exemplar (see topics like: Software V&V: Verification Testing Features and The Validation Sprint Explained). Having presented the meat of the process in our first series, we are excited to move forward on a second blog series, Agile Tooling for High Assurance Software Development.
In this series, Dean and I will provide examples of tools that many of us have in our own environment, such as Rally, Quality Center, and SVN, and show how these products can be used to support the compliance documentation that is commonly produced for audits in regulated environments. We will provide the community with best practices for using Rally as well as a best of breed solution that integrates Rally to other products.
The series will include posts like…
1) Use Rally to track and report on the basics – Define | Verify | Build
2) Achieve tight traceability and reporting from Product Requirements to System Requirement to Verification & Validation
3) Don’t overlook the implementation of the Validation Sprint
4) Testing and test traceability in High Assurance Environments
In conjunction with this series, Rally will release new applications like an improved traceability matrix and a SRS report that Rally customers will be able to take advantage of. In addition, we encourage you to share your suggestions for reporting that would help to automate the compliance process for your Agile team. If you are a Rally user, please enter your ideas at Rally Ideas and tag it as “compliance.” Or, feel free to send me an email at email@example.com.