This episode has been published on September 3rd, 2018
Welcome to the sixth episode of Automating Quality. Today’s topic is data integrity — a current, hot-topic in the regulated space. Mandy is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends.
Today, Mandy is joined by her co-host (and founder and CEO of Solabs), Philippe Gaudreau. Together, they interview their data integrity expert, Rich Greer. Rich has a ton of insight and expertise in this area, having been in the industry for around 29 years. He’s had varying roles within engineering, validation, and quality.
Rich provides some great takeaways such as: instituting a data integrity program for the first time, re-assessing your current program for opportunities for improvement, common gaps and misunderstandings around data integrity, and more.
[:40] About today’s topic and guest.
[1:53] Rich gives an intro to his industry background.
[3:24] What is data integrity? And what are some key considerations when trying to implement a data integrity program?
[7:10] Key factors related to data integrity when considering implementing and maintaining your GxP electronic systems.
[8:58] Rich explains some tactical strategies to manage legacy GxP systems.
[15:05] Some common gaps and misunderstandings Rich has seen around data integrity and maintaining compliance.
[18:38] If data integrity has been compromised, what are some critical actions an organization must take to remediate?
[23:26] Summarizing key points from this week’s episode.
[24:00] How to get a hold of Mandy and Rich.
[24:20] About next week’s episode.
Mentioned in this Episode: