Episode 33: Case Study for Implementing an EQMS from a System Owner’s Lens
Release Date: 02/04/2020
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, we explore Mandy’s takeaways from recent quality conferences she attended, from management accountability to the importance of managing data integrity. Key Takeaways 02:06: What are the key conferences Mandy attended this year? 04:49: The importance of keeping management accountable for quality objectives....
info_outlineWelcome to the 33rd 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, Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau, to bring you a bit of a different episode than usual! They’re going to be walking listeners through a case study that is incredibly relevant to their friends and partners in life sciences in terms of system ownership. These are the things that you may encounter and should consider as part of a case study related to implementing a new EQMS system from the system owner’s lens within the quality function.
Philippe will be playing the role of Mandy’s guest expert as well as the QA Director who will be owning this initiative in the case study. Together, Mandy and Philippe will be walking listeners through what they feel are some of the most important things that you’ll face if you have not yet engaged in this type of initiative.
Key Takeaways:
[:33] Mandy Gervasio welcomes Philippe Gaudreau to the podcast and introduces today’s subject: a case study for implementing a new EQMS from the system owner’s perspective.
[2:55] Mandy explains the roles that she and Philippe will be taking for the case study.
[3:29] Mandy explains the case study format/situation they will be exploring in today’s episode.
[6:06] Philippe starts by providing his first (of three) recommendations for beginning the implementation process.
[7:00] Philippe highlights the areas and roles where you need different people in this process.
[9:18] Philippe stresses the importance of having a steering committee involved.
[10:07] Philippe continues explaining other important and key roles in this process.
[12:36] Mandy highlights some other fantastic episodes related to today’s subject for listeners who want to dive deeper and learn more.
[14:07] Philippe provides his second recommendation for the implementation process.
[17:35] Philippe gives his final recommendation.
[19:19] Mandy and Philippe both stress the importance of having a migration plan for data management.
[23:26] Mandy poses a scenario to Philippe about integrating a new EQMS into their current ERP system. Philippe speaks about what some of the project risks could be, what to consider, and the general timeline.
[26:54] Philippe recommends some best practices for organizations to adopt as part of this rollout.
[32:00] Mandy gives some advice and further recommendations on episodes to check out after listening to today’s!
[33:20] Mandy explains the importance of planning for failure as well as success.
[34:52] Mandy thanks Philippe for providing his expert advice on this week’s podcast.
[35:05] Philippe introduces the new Automating Quality LinkedIn community group.
[36:10] Mandy thanks listeners for tuning in!
Mentioned in this Episode:
Automating Quality Ep. 32: “Major Trends in Automation for the Life Sciences Industry in 2020”
Automating Quality Ep. 29: “Data Migration and Data Integrity with Philippe Gaudreau”
Automating Quality Ep. 12: “Validating a Cloud-Based Solution with Philippe Gaudreau”
Automating Quality Ep. 1: “Change Management with Rachel Fountain”
Automating Quality Ep. 5: “The Do’s and Don’ts of Change Management with Rachel Fountain”
Automating Quality Ep. 14: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds” (Lisa Helmonds is also featured in episodes: 15, 17, 18, 19 & 20)
Automating Quality Ep. 3: “Phase Appropriate Quality with Mary Senica”