Automating Quality18 Marras 2025

Episode 63 - Qualification of Software Vendors with Masha Ivankovic

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 solabs-podcast@solabs.com for suggestions or inquiries.
For direct inquiries, Masha can be reached at: masha.ivankovic@monbeltech.com

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