This episode was published on June 9th 2020.
Welcome to the 38th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is a little different than usual. Philippe Gaudreau will be joining Mandy as a co-host in a conversation with guest expert Ben Locwin. Ben is the SVP of Quality at Lumicell and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
This week, they are discussing Data Integrity and Data Governance in today’s landscape. Ben explains the difference between data integrity and data governance, discusses the challenges of remote work during COVID-19 from a GxP perspective and breaks down some tips for companies to incorporate work from home in their company culture in a safe and efficient way!
0 :33 : Mandy introduces today’s co-host Philippe Gaudreau.
1:22 : Mandy introduces today’s guest, Ben Locwin.
2:15: Today’s topic is Data Integrity and Data Governance in today’s remote work culture.
3:02: Ben provides an overview of his background in Life Sciences.
9:15: Ben explains the difference between data integrity and data governance.
9:50: The guests discuss the unique challenges for handling work from home and COVID-19 from a GxP Data Integrity perspective?
11:57: Philippe details some of the dangers for data integrity with employees working from home and shares his opinion on the future of online security.
14:31: Ben stresses the importance of the Quality / Regulatory and IT / Security team members work hand in hand to ensure the integrity of data.
17:15: Ben discusses the delicate balance between ease of use and standardization of inputs and outputs within software.
20:14: The group discusses tips and tricks for remote workers to improve their efficiency.
23:39: Ben insists on the importance of having a routine on the human psyche.
26:10: Mandy insists on the importance of recording important meetings to keep track of information
27:28: Philippe gives some tips for companies to incorporate work from home in their company culture in the long term.
30:27: Mandy suggests reviewing data governance policies and ensuring that the team is comfortable with working from home.
31:55: Ben stresses the importance of having clear data governance policies in the future.
33:53: Mandy thanks Ben and Philippe and reflects on today’s learnings.