Episode 63 - Qualification of Software Vendors with Masha Ivankovic
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

Jaksot(64)

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

Welcome to the 32nd 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 ep...

21 Tammi 202026min

Episode 31: Guest Tribute Show: 'Best of' Moments from the Last Two Seasons!

Episode 31: Guest Tribute Show: 'Best of' Moments from the Last Two Seasons!

Welcome to the 31st 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! And today, s...

10 Joulu 201927min

Episode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie Bourgouin

Episode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie Bourgouin

Welcome to the 30th 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 e...

26 Marras 201929min

Episode 29: Data Migration and Data Integrity with Philippe Gaudreau

Episode 29: Data Migration and Data Integrity with Philippe Gaudreau

Welcome to the 29th 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 is ...

12 Marras 201933min

Episode 28: Regulatory Convergence and Its Impact on the Life Sciences Industry

Episode 28: Regulatory Convergence and Its Impact on the Life Sciences Industry

Welcome to the 28th 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 e...

16 Loka 201913min

Episode 27: The LIR Process and Key Considerations for Robustness with Kathryn Landes

Episode 27: The LIR Process and Key Considerations for Robustness with Kathryn Landes

Welcome to the 27th 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 on ...

2 Loka 201926min

Episode 26: Current Hot Trends in the Medical Device Industry

Episode 26: Current Hot Trends in the Medical Device Industry

Welcome to the 26th 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 s...

4 Syys 201916min

Episode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

Episode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

Welcome to the 25th 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 ep...

6 Elo 201931min

Suosittua kategoriassa Liike-elämä ja talous

sijotuskasti
mimmit-sijoittaa
rss-rahapodi
psykopodiaa-podcast
herrasmieshakkerit
ostan-asuntoja-podcast
rahapuhetta
rss-rahamania
rss-lahtijat
rss-seuraava-potilas
leadcast
rss-merja-mahkan-rahat
rss-40-ajatusta-aanesta
rss-porssipuhetta
rss-levosta-kasin-yrittajyys
rss-sisalto-kuntoon
rss-vaikuttavan-opettajan-vierella
rss-ma
rss-bisneksen-pehmea-puoli
rss-draivi