Episode 66 - From Framework to Practice: Governing AI in GxP Environments with Niyati Patel
Release Date: 04/23/2026
Episode 66 - From Framework to Practice: Governing AI in GxP Environments with Niyati Patel
Automating Quality
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 Patel, Strategic Quality and Compliance Advisor, shifting from theory to execution: how organizations are operationalizing AI in GxP environments. This episode dives into the practical realities of AI governance, focusing on lifecycle management, data boundaries, and the human role in processes involving AI. The discussion unpacks how...
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Episode 65 - From CSV to CSA: Rethinking Validation in the Age of AI with Niyati Patel
Automating Quality
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 Compliance Advisor with 20+ years of experience across pharma, biotech, medtech, and regulated digital implementations. Niyati specializes in the intersection of quality, validation, and digital transformation. Together, they unpack how validation is evolving in the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA). The...
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Episode 64: Compliance in the Biotech Industry with Paul Michel
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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 in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing. Together, they explore the realities of GxP compliance in biopharma manufacturing...
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Episode 63 - Qualification of Software Vendors with Masha Ivankovic
Automating Quality
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...
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Episode 62: Leveraging Internal Audits with Jim Ferguson
Automating Quality
Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In today’s episode, our host Philippe welcomes Jim Ferguson, President and Owner of NuQual Consulting. With over 25 years of experience in the life sciences industry, Jim brings deep expertise in supplier quality and compliance. Together, they dive into the world of internal audits — how they can be used not only to maintain compliance but also to proactively identify and resolve potential observations before a regulatory inspection takes place. Key...
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Episode 61: Value Added Quality with Ed Siurek
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Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In today’s episode, Ed and Philippe explore how quality can bring added value to a company and discuss strategies to shift organizational mindsets to unlock the full potential of quality departments. Ed Siurek brings over 30 years of hands-on experience in applying quality standards and ensuring regulatory compliance in the pharmaceutical and medical device industries. He has trained hundreds of quality professionals and is a strong advocate for positioning quality...
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Episode 60: Investigative Methods with Michael Tyo
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today’s episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaway 01:24 Introducing today’s guest: Michael Tyo 01:55 Today’s topic is investigative methods and what happens when...
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Episode 59: Introduction to Investigations with Michael Tyo
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Automating Quality Episode 59 – Inspection Readiness with Michael Tyo Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today’s episode, we discuss inspection readiness, from why we are doing them to how to conduct investigations properly. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaways 00:42 Introducing today’s guest: Michael Tyo 01:42 Today’s subject is the...
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Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the second in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. In this episode, we discuss the definition of AIBOM, how it differs from SBOM, and take an educated guess at their future. Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape,...
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Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia
Automating Quality
Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices. "Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely...
info_outlineWelcome 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 Patel, Strategic Quality and Compliance Advisor, shifting from theory to execution: how organizations are operationalizing AI in GxP environments.
This episode dives into the practical realities of AI governance, focusing on lifecycle management, data boundaries, and the human role in processes involving AI. The discussion unpacks how organizations can structure AI frameworks around intended use, risk classification, data governance, and continuous monitoring, highlighting that AI success is driven less by the model and more by people, policies, and control systems.
The conversation also explores what can and cannot be shared with AI tools, outlining clear distinctions between acceptable, restricted, and prohibited use cases. From SOP generation to critical quality decisions, Niyati breaks down how leading organizations are defining guardrails to enable safe adoption.
Finally, the episode emphasizes that AI is an assistant, not a decision maker.
Key Takeaways
01:22 Looking back at part 1
02:00 Introducing today’s guest Niyati Patel
05:00 How do organizations safely use AI right now?
07:55 Continuous monitoring is critical for systems that evolve over time
10:10 Which data must be protected when giving access to data to your AI?
11:30 How do you get comfortable using AI as an organization?
15:51 What are some good use cases for AI use in regulated industries?
Please contact us at solabs-podcast@solabs.com if you have questions or comments.
Mandy Gervasio
Niyati Patel
Philippe Gaudreau