28 OCT 2021 · Is "Documentation" really the focus of CSA even if it's placed at the lowest level of the pyramid? In this episode, I'll cover the last in a series dedicated to Computer Software Assurance (CSA), from Critical Thinking, Assurance Needs, Testing, and now Documentation.

20 OCT 2021 · CSA Testing is the third level tier in the upended pyramid that is poised to disrupt Computer System Validation (CSV) or at least provide a refresher for Risk-Based Validation with a Least Burdensome approach, along with different testing modalities such as ad hoc, exploratory, and automated testing. This podcast dives into Testing in CSA, along with highlighting a root cause common with poor test scripts and test steps.

13 OCT 2021 · CSA recommends Assurance Needs, right after Critical Thinking. What is Assurance Needs? This episode dives into this topic shedding light, based upon industry experience, on what to address in this phase of CSA validation.

6 OCT 2021 · Would Facebook, Instagram, and WhatsApp have gone down if they qualified their infrastructure? Didn’t they have change control, configuration management, disaster recovery, and business continuity? These are all practices we employ in life science. Why doesn’t the world's largest social media platform do the same or similar? Or did they really go down accidentally? This podcast sheds light on how and why infrastructure qualification, including IaaS, should be followed as a practice.

22 SEP 2021 · CSA, short for Computer Software Assurance, is poised to make improvements on the 20-year-old Computer System Validation (CSV) practices life science organizations have been following. Is it new? Why all the hype? What is it, exactly? This episode explains how CSA is different from CSV, promising new opportunities that may be around the corner, and simply a better way to do something required by law (i.e., Validate systems).

15 SEP 2021 · We're living in the 4th Industrial Revolution, where the cyber world merges with the physical world, becoming cyberphysical. This podcast identifies key technologies used in Industry 4.0, referred to as Pharma 4.0 in Life Science, paving the way to the Factory of the Future.