Explore the world of software testing and computer systems validation for regulated industries. The who, what, when, why and how of best practices within software quality assurance.
A Critical Look at Computer Software Assurance (CSA): Is it Really a Thing?
A risk-based approach to Computerized System Validation has been around for over 20 years, so what's the hype about CSA? Join us in this episode as we are joined by our amazing guest, Dr. Bob McDowall, to explore this question.
Bob McDowall is an analytical chemist with 50 years of experience including 15 years working in the pharmaceutical industry and 29 years as a consultant to the industry and suppliers to the industry. He has been involved with the validation of computerized systems for over 35 years and is the author of the second edition of a book on the validation of chromatography data systems published in 2017 and a book on data integrity for regulated laboratories in 2019.
Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns. One such column in September 2021 was entitled Does CSA Mean Complete Stupidity Assured? It is available online at:
Artificial Intelligence and Machine Learning in Life Sciences, with Eric Staib
Artificial Intelligence and Machine Learning are being used to great results in a variety of ways across numerous industries, but what does it mean for the Life Sciences industry? How can Life Sciences teams that want to stay on the cutting edge begin to practically incorporate AI/ML to drive better, more efficient results across their organizations?
If you're looking for answers, you've come to the right place. Give this podcast a listen to hear subject matter expert, Eric Staib, share his incredibly insightful and valuable thoughts on the topic.
*Disclaimer: Eric Staib participated in the podcast as an individual subject matter expert and contributor. The views and opinions he shares are not necessarily shared by his employer, Signant Health. Nor should any reference to specific products or services be interpreted as commercial endorsements by Signant Health.
Strategic and Risk-Based Testing, with Ajay Pandey
Dori welcomes long-time colleague and Sr. Manager of TCoE at Biogen, Ajay Pandey to the podcast. With extensive knowledge of application testing and software quality in Life Sciences, Ajay shares his insights on setting up a strategic Testing Center of Excellence framework, as well as the importance of incorporating risk-based testing.
Ajay is a Senior IT professional with over 19 years of progressive experience in management and governance of Application Lifecycle Management/SDLC toolsets in large Medical Device and Bio-Pharmaceutical space as well as a Certified Project Management Professional (PMP).
Give it a listen, and please don't forget to rate and subscribe wherever you get your podcasts.
*Disclaimer*: Ajay has agreed to participate in the Software Quality Today podcast as an individual subject matter expert. The views and opinions he shares are his own and are not necessarily shared by his employer, Biogen. Nor should any reference to specific tools or products be interpreted as commercial endorsements by Biogen.
Breaking Down SAP Testing and More, with Micro Focus Expert, Don Jackson
Dori is able to grab some time with Micro Focus SAP expert, Don Jackson. From automating SAP, to process management, to streamlining maintenance of components and assets, Don has a variety of insights he shares based on his years of experience. In addition, he is able to share some extremely valuable tools that Micro Focus brings to the world of SAP testing/maintenance which help their clients in the realm of SAP and beyond.
General SAP testing questions? SolMan questions? S4HANA questions? Dori and Don cover it all, so tune it!
A bit more about Don: Don Jackson is an IT professional with 20+ years of experience delivering testing and quality initiatives. Mr. Jackson is recognized in the IT Quality/Testing industry as a thought leader and has spoken at multiple conferences, webinars, seminars, and publications. Don is currently the Chief Technologist for ADM at Micro Focus.
Disclaimer: Don is appearing as an individual subject matter expert, and the views and opinions he shares are not necessarily shared by his employer, Micro Focus.
As always, please don't forget to rate and subscribe wherever you get your podcasts.
Raising the Software Quality Bar at the Coffee Bar, with Ken Shitamoto
In this episode, Dori sits down with fellow CSV and CSA guru Ken Shitamoto for some outdoor, morning coffee on the final day of the KENX Computer Systems Validation and Software assurance conference.
Together, they share their insights not only on CSV/CSA, but the overall state of software quality in Life Sciences and what we as industry professionals can do to collectively raise the bar as we move into 2022.
As mentioned in the episode outro, they discuss some recent comments from Cisco Vicenty where he discusses the current status of the CSA draft guidance. To further clarify, I wanted to direct you to the link below at about the 8:30 mark of the publicly available MDIC presentation recorded on December 8th in which Cisco elaborates on where the draft guidance currently is in the process.
View presentation here.
Thanks for tuning in and don't forget to subscribe wherever you get your podcasts to be notified whenever new episodes are released.
CSA and CSV from a Beach in SD, with Sagax Team CEO, Rohit Tyagi
Join us from a beach in San Diego, California, at the KENX Computer Systems Validation and Software Assurance conference. In this episode, Dori is joined by industry colleague and subject matter expert, Rohit Tyagi, President and CEO of Sagax Team.
They discuss some of the presentations and topics that have been covered at the KENX conference this year, as well as general thoughts, challenges, and successes that folks are currently experiencing related to CSV modernization and CSA adoption strategies.
Please listen to get all their insights, but please don't forget to rate and subscribe wherever you get your podcasts. Also, please reach out to Rohit and Sagax team via the LinkedIn profiles and URLs below:
Sagax Team Website: https://www.sagaxteam.com/
Rohit's LinkedIn: https://www.linkedin.com/in/247results/?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAACDuxYBeNHQ7o6FuO-IhNvldXFdFjGNUig