Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!
 
Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Quality, what to focus on first when implementing a quality system and the differences between Computer Software Validation (CSV) and  Computer Software Assurance (CSA), and more!
 
Key Takeaways
02:17 Introducing today’s guest: Joseph Silvia, Director of Software Quality Training and Instruction and Lead Auditor at Oriel Stat A Matrix
03:33 What is the Case for Quality?
05:23 Joseph discusses the importance of having quality at the core of what you do as opposed to adding it as an afterthought
07:44 What is the first thing you should focus on when implementing a quality system?
10:55 Philippe shares his experience on implementing QM10 at SOLABS as part of our quality practices
12:53 The difference between Computer Software Validation (CSV) and Computer Software Assurance (CSA) and how this is impacting risk management
17:38 Thanking Joseph and our listeners for today’s episode!
Contact Joseph at jsilvia@orielstat.com or on LinkedIn
Oriel STAT A MATRIX: www.orielstat.com
Reach out to us at solabs-podcast@solabs.com