Rephonic
Artwork for Automating Quality
Artificial Intelligence
Internal Audits
Vendor Qualification
Regulatory Compliance
Biopharmaceuticals
Software Validation
CSA (continuous System Assurance)
CSV (computer System Validation)
Gxp
Quality Management System
Biologics
AI In Regulated Environments
Life Sciences
Quality Systems
Health Canada
FDA
Monbel Consultants
ISO Certification
Risk Management
Cdmos

Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing... more

PublishesInfrequentlyEpisodes66Founded8 years ago
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Artwork for Automating Quality

Latest Episodes

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments.

In Part 2 of this three-part series, Mandy and Philippe continue the conversation with Niyati P... more

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments.

In this episode, Mandy and Philippe are joined by Niyati Patel, Strategic Quality and Complianc... more

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 Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience i... more

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 ... more

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Recent Guests

Niyati Patel
Strategic quality and compliance advisor in life sciences
Episode: Episode 65 - From CSV to CSA: Rethinking Validation in the Age of AI with Niyati Patel
Paul Michel
Senior consultant with SkillPad Consulting
SkillPad Consulting
Episode: Episode 64: Compliance in the Biotech Industry with Paul Michel
Masha Ivankovic
President and owner of Monbel Consultants
Monbel Consultants
Episode: Episode 63 - Qualification of Software Vendors with Masha Ivankovic
Jim Ferguson
Owner and President of NuQual Consulting
NuQual Consulting
Episode: Episode 62: Leveraging Internal Audits with Jim Ferguson
Ed Siurek
Quality and life science consultant
ES3 Solutions
Episode: Episode 61: Value Added Quality with Ed Siurek

Host

Philippe Godot
Co-host with Mandy, focusing on how digital quality systems work in practice

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Talking Points

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Episode 62: Leveraging Internal Audits with Jim Ferguson
Q: What is the role of internal audits and how can they help prepare for external or regulatory audits?
Internal audits provide a structured review of the quality management system, help identify deficiencies before regulators do, and require senior management buy-in, proper CAPAs, and robust training to convert findings into sustainable improvements.
Episode 66 - From Framework to Practice: Governing AI in GxP Environments with Niyati Patel
Q: What practical framework should organizations use to govern AI life cycle in regulated environments, especially around data, change management, and monitoring?
She describes a life cycle framework starting with intended use and risk classification, then data governance and access, data retention, change management with risk-based assessment of prompts and model updates, and finally continuous monitoring using KPIs, recognizing that models evolve over time and require ongoing oversight.
Episode 66 - From Framework to Practice: Governing AI in GxP Environments with Niyati Patel
Q: Can you kick us off and share a bit about your background and the quality and compliance challenges you're most focused on right now?
Niyati outlines her experience in strategic quality and compliance across pharma, med tech, and biotech, emphasizing regulated technology implementations, validation, inspections, audits, and readiness, with a strong focus on applying AI safely in GXP contexts.

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Frequently Asked Questions About Automating Quality

What is Automating Quality about and what kind of topics does it cover?

The show centers on leveraging automation to improve quality and compliance in regulated life sciences, with frequent discussion of AI governance in GxP contexts, data integrity, vendor qualification, and internal audits. Episodes consistently explore practical implementations of quality systems, lifecycle management, and real-world challenges in biopharma, CDMOs, and software validation, often featuring expert guests who bring deep experience in governance, risk management, and regulatory expectations. A standout aspect is the clear focus on turning complex regulatory concepts into actionable guidance, including human-in-the-loop oversight, risk-based approaches, and continuous monitoring in AI-enabled environments. This makes it a strong ... more

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1. SmartLess

How many episodes of Automating Quality are there?

Automating Quality launched 8 years ago and published 66 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Automating Quality?

Recent guests on Automating Quality include:

1. Niyati Patel
2. Paul Michel
3. Masha Ivankovic
4. Jim Ferguson
5. Ed Siurek

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