Quality and Computer Software Assurance

On today’s episode, Stacey Bruzzese welcomes Steve Thompson, Director Industry Solutions at ValGenesis.

Stacey and Steve talk about a variety of topics:

• Why is the FDA’s Case for Quality which launched in 2011 just now being implemented on a more widespread level?
• What challenges are posed by implementation?
• Steve walks through the core components of the Case for Quality
• Although it will roll out as a voluntary pilot program, what does Steve see as the progression over the coming months and years?

Mr. Thompson has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers.  He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.