{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia","description":"Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between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! &amp;nbsp; 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 &amp;nbsp;Computer Software Assurance (CSA), and more! &amp;nbsp; Key Takeaways 02:17 Introducing today\u2019s 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\u2019s 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 ","author_name":"Automating Quality","author_url":"https:\/\/docs.solabs.com\/hc\/en-us\/sections\/360006683193-Automating-Quality-Podcast","html":"<iframe title=\"Libsyn Player\" style=\"border: none\" src=\"\/\/html5-player.libsyn.com\/embed\/episode\/id\/26429118\/height\/90\/theme\/custom\/thumbnail\/yes\/direction\/forward\/render-playlist\/no\/custom-color\/88AA3C\/\" height=\"90\" width=\"600\" scrolling=\"no\"  allowfullscreen webkitallowfullscreen mozallowfullscreen oallowfullscreen msallowfullscreen><\/iframe>","thumbnail_url":"https:\/\/assets.libsyn.com\/secure\/item\/26429118"}