Automating Quality – Détails, épisodes et analyse

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 solabs-podcast@solabs.com 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 solabs-podcast@solabs.com for questions or feedback!

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready state over time.

Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies for being and staying inspection-ready.

Key Takeaways:

00:42 Introducing today's guest: Caroline Guay-Adams

03:23 Why is inspection readiness necessary for Life Sciences companies?

05:24 How do you establish a strategy to be and stay inspection-ready?

08:00 What are the requirements for a company to call itself inspection-ready?

13:00 Which mindset is necessary for this strategy to remain successful over time?

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA's expectations regarding the use of risk assessment tools.

Key Takeaways:

01:11 Introducing Michael and his Background

02:31 Does the FDA have a clear expectation for the use of risk assessment tools?

06:13 The importance of a risk plan

09:20 Why companies must all have an SOP for risk assessment

Contact us at solabs-podcast@solabs.com

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters can be leveraged as a source of information on the FDA's current areas of focus and how monitoring them can help avoid the FDA's attention.

Key Takeaways

01:04: Michael introduces himself and his background

02:21: How can companies use warning letters as a source of information on the FDA's current area of focus

04:31: Michael shares a statistical analysis he conducted on warning letters in 2023

08:52: How warning letters give you an idea of what happened at the company

12:31: Understanding warning letters helps companies avoid the FDA's attention

Contact us at solabs-podcast@solabs.com

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by  Philippe Gaudreau, CEO at SOLABS, and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma.

In this episode, Mandy and Philippe discuss supplier management from establishing a relationship with new suppliers to maintaining this relationship and keeping the trust between your two organizations alive.

Key Takeaways:

01:30 Mandy discusses her current role and how it is linked to supplier management

03:40 Being able to work with partners that allow you to operate as one team in a seamless way is an incredible success factor

04:37 Mandy points red flags when entering a relationship with a supplier

07:15 Communicating only when there are problems to manage is a risky behavior

09:03 From a GCP perspective, how can you establish a good relationship with CROs and other suppliers?

13:26 How do you maintain your relationship with those suppliers and keep the trust alive and active?

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma.

In this episode, we explore Mandy's takeaways from recent quality conferences she attended, from management accountability to the importance of managing data integrity.

Key Takeaways

02:06: What are the key conferences Mandy attended this year?

04:49: The importance of keeping management accountable for quality objectives.

06:24: Accountability now revolves around individual responsibilities.

10:21: Data integrity is a recurring theme in discussions.

14:30: Training on data integrity has evolved in recent years.

16:07: Supplier Management is another important topic.

Contact us at solabs-podcast@solabs.com

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very special 50th episode!

We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common challenges GMP shopfloor companies have in terms of analytics, how this evolved over time, and more!

Key Takeaways

01:01 Introducing today's return guest: Jamie Villeneuve from NexGen Analytics

02:35 What are some of the common challenges in GMP companies from an analytics standpoint?

05:01 What departments need input from analytics?

07:31 How has analytics evolved over time for GMP companies?

10:11 New nomenclature and approach for analytics

11:38 Why do companies invest more and more in analytics?

13:03 The top 5 metrics GMP shopfloor analytics companies need to track

14:42 Thank you to Jamie for joining us for this special episode #50!

Contact Jamie at jvilleneuve@solabs.com

Contact us at solabs-podcast@solabs.com

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!

We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from establishing the organization's goals to providing the right information to the right people at the right time.

Key Takeaways

01:58 Introducing today's guest: Jamie Villeneuve from NexGen Analytics

03:19 Who needs information from analytics in an organization?

05:36 How do you know what information is relevant to report on?

08:52 How do you communicate analytics effectively to all staff at a company?

11:40 Is there a process to review metrics over time and ensure what is measured stays up to date with the company's needs?

15:12 Thank you to Jamie for joining us!

Contact Jamie at jvilleneuve@solabs.com

Contact us at solabs-podcast@solabs.com

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!

We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shares his expertise on Supplier Management Quality for the medical devices industry. We discuss the onboarding process of new suppliers, the future of remote versus on-site audits, and more!

Key Takeaways

00:38 Introducing Joseph Silvia and Oriel STAT A MATRIX

02:53 Who are the main parties involved in the medical devices supply chain?

04:15 What is the process to getting a new supplier on board?

07:56 Are all audits in the future going to be remote?

10:04 Do suppliers change their processes to make themselves easier to audit?

12:55 Thanks to Joseph and our listeners for this great episode!