Welcome to the first episode of Automating Quality. Today’s show is focused on change management — a vital topic for the Life Sciences and regulated industry. Your host is Mandy Gervasio, Sales Engineer and Quality Best Practice SME at Solabs. She is joined by her co-host, Philippe Gaudreau, CEO of Solabs.
In this episode, Mandy and Philip interview Rachel Fountain. Rachel is currently a Principal Consultant, working in the software industry with a focus on quality and risk management. She has amassed 14 years of experience in the Life Sciences industry as a quality expert — implementing change management systems and helping companies move from one automated system to another.
Today, Mandy and Rachel discuss strategies to streamline the change management process by utilizing an automated solution, key items that have the most impact when moving into an automated solution, and Rachel’s recommendations for smaller organizations looking to implement a change management program from scratch.
[:14] About today’s episode on change management with Rachel .
[1:00] Rachel’s background, passions, and current work.
[2:26] Strategies to streamline the change management process by utilizing an automated solution.
[7:19] Rachel’s position on assessing the performance of an organization or change management system in regards to cycle times.
[10:20] Has Rachel seen a reduction in audit observations upon implementation of an automated change control solution?
[12:10] The current thinking and expectations around implementing effectiveness checks as related to change management. Is it mandatory?
[14:40] Some key items that have the most impact when moving into an automated solution vs a manual change control process.
[19:57] Rachel’s recommendations to smaller organizations looking to implement a change management program from scratch.
[23:25] Summarizing this week’s episode, how to get in touch with Mandy and Rachel, and about next week’s episode.
Mentioned in this Episode:
Effectiveness Review Performance
Rachel Fountain’s Linkedin Profile