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 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 [email protected] if you have questions or comments. Mandy Gervasio Niyati Patel Philippe Gaudreau

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 discussion challenges common misconceptions, emphasizing that the real shift is toward risk-based thinking, lifecycle control, and deeper system understanding rather than documentation-heavy compliance.

The conversation then moves into AI. Niyati outlines how organizations should rethink validation frameworks to focus on boundaries, governance, and human oversight, positioning AI as decision support rather than decision-making.

Through practical examples and real-world use cases, this episode sets the foundation for understanding how quality leaders can responsibly adopt AI while maintaining compliance, control, and trust.

Key Takeaways

• 01:09: Introducing today's topic
• 03:24: Niyati's background
• 05:43: What is CSV (and its limitations)
• 09:06: What CSA actually changes
• 10:41: Validation rigor is NOT reduced
• 14:00 Why AI breaks traditional validation
• 16:23: Why AI must be used for decision support, not autonomous decision making
• 19:13: Example of AI validation framework
• 23:40: What validation now proves

Please contact us at [email protected] if you have questions or comments. Mandy Gervasio Niyati Patel Philippe Gaudreau

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 — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.

Key Takeaways

02:11 Why biologics manufacturing is fundamentally more complex than small molecule production

04:10 How living cell systems introduce variability and demand tight process control

05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone

10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance

13:06 The growing demand for advanced quality skills in biologics and digital environments

17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches

20:47 Why automation and digitalization are critical to closing the CDMO capacity gap

Contact Paul Michel on LinkedIn here: Paul Michel (He/Him) | LinkedIn

Contact us at [email protected] for questions or feedback!

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]

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 Takeaways 01:22 Introducing today's guest, Jim Ferguson from NuQual Consulting 02:18 What quality-focused events has Jim been attending lately? 04:30 How can internal audits help organizations prepare for regulatory inspections or other types of audits? 07:25 What is the value of outsourcing internal audits? 08:35 How can companies ensure that audit findings actually lead to meaningful changes? 12:57 What does a strong response to internal audit findings look like? 17:30 What are some common pitfalls organizations tend to overlook during internal audits?

Contact Jim at https://nuqualconsulting.ca/

Contact us at [email protected]

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 as a driver of business value. After 13 years with a consulting firm, Ed recently transitioned full-time to his own company, ES3 Solutions Inc.

00:53 – Introducing Ed Siurek 02:20 – Why is quality sometimes perceived as a cost? 05:50 – Always remember: our products are ultimately used on people 09:02 – "If it's not written down, it didn't happen" 10:20 – Use your risk report — don't let it collect dust 13:20 – How are regulatory bodies viewed in the industry today? 21:15 – What is the role of a quality plan?

Contact us at [email protected] for questions or suggestions. Contact Ed Siurek at Always improving ES3 Solutions

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 things go wrong

03:36 The Fishbone method

06:28 Why human error cannot be a root cause?

07:55 The 5 Whys method

09:35 What needs to be included in the investigation report?

11:30 What does the FDA expect from investigations?

12:38 Lessons from recent FDA's warning letters

Contact Michael at [email protected], Tyo Biotechnology Consulting

Contact solabs at [email protected]

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 investigations, from why they exist to how they must be performed

02:22 Why are we doing investigations?

04:21 What may trigger an investigation?

08:04 What must be investigated?

10:00 Who is responsible for doing investigations?

14:41 What are the tasks once the investigation is launched?

Contact Michael at [email protected], Tyo Biotechnology Consulting

Contact solabs at [email protected]

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, and we frequently refer to him for his regulatory expertise.

Key Takeaways;

01:05 Introducing guest Joseph Silvia

02:20 What is the concept of AIBOM?

04:23 Why AIBOM and SBOM should be separate discussions

07:45 How does open-source software impact those bills of material

11:22 How do you assess the risk of an AIBOM?

Contact us at [email protected]

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 knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise.

Key Takeaways

01:10 Introducing today's guest: Joseph Silvia

02:35 What is an SBOM?

04:24 What is the history of SBOM?

05:50 Now, the government is getting involved and SBOM is picking up steam.

06;35 What is the FDA's expectation on this topic for the medical devices industry?

09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it?

11:38 Who is responsible for SBOM within organizations?

14:37 Where can listeners learn more about this topic?

Reach Joseph at [email protected]

Contact us at [email protected]