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Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
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Episode 63 - Qualification of Software Vendors with Masha Ivankovic

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Manage episode 520025353 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management.

In this episode, our host Philippe welcomes Masha Ivankovic, President and Owner of Monbel Consultants. With more than 15 years of experience supporting pharmaceutical and biotech companies, Masha has led complex engineering, validation, and regulatory projects across highly regulated environments.

Together, they explore the increasingly critical topic of qualifying software providers, why it matters, when it should start, and how proper qualification streamlines software validation and long-term compliance. Masha breaks down practical risk-based strategies, key questions to ask vendors, and how to align expectations early to ensure smoother implementations.

Key Takeaways

00:41 Introducing today's guest, Masha Ivankovic from Monbel Consultants 01:25 Masha's background and the services Monbel Consultants provides 02:37 Why qualifying a software provider is now essential in regulated industries 04:47 When vendor qualification should begin vs. when it usually does 06:30 How risk-based thinking shapes software provider qualification 07:40 Examples of risk criticality 09:19 Key qualification criteria and questions to assess provider maturity 11:10 How strong vendor qualification improves software validation success 13:13 What triggers re-qualification and typical lifecycle expectations 15:10 Closing thoughts and where to learn more about Monbel Consultants

Contact [email protected] for suggestions or inquiries. For direct inquiries, Masha can be reached at: [email protected]

  continue reading

63 episodes

Artwork
iconShare
 
Manage episode 520025353 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management.

In this episode, our host Philippe welcomes Masha Ivankovic, President and Owner of Monbel Consultants. With more than 15 years of experience supporting pharmaceutical and biotech companies, Masha has led complex engineering, validation, and regulatory projects across highly regulated environments.

Together, they explore the increasingly critical topic of qualifying software providers, why it matters, when it should start, and how proper qualification streamlines software validation and long-term compliance. Masha breaks down practical risk-based strategies, key questions to ask vendors, and how to align expectations early to ensure smoother implementations.

Key Takeaways

00:41 Introducing today's guest, Masha Ivankovic from Monbel Consultants 01:25 Masha's background and the services Monbel Consultants provides 02:37 Why qualifying a software provider is now essential in regulated industries 04:47 When vendor qualification should begin vs. when it usually does 06:30 How risk-based thinking shapes software provider qualification 07:40 Examples of risk criticality 09:19 Key qualification criteria and questions to assess provider maturity 11:10 How strong vendor qualification improves software validation success 13:13 What triggers re-qualification and typical lifecycle expectations 15:10 Closing thoughts and where to learn more about Monbel Consultants

Contact [email protected] for suggestions or inquiries. For direct inquiries, Masha can be reached at: [email protected]

  continue reading

63 episodes

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