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 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

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–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 solabs-podcast@solabs.com

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 mtyo@tyobio.com, Tyo Biotechnology Consulting Contact solabs 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 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 solabs-podcast@solabs.com

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 series on Inspection Readiness featuring guest Caroline Guay-Adam! In this episode, we dive into tips and tricks for maintaining Inspection Readiness including first time right, the importance of the Inspection Manual, and more! 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 01:18 Introducing today's guest, Caroline Guay-Adam. 02:46 The importance of verifying the effectiveness of corrective actions. 04:55 Focus on what the inspector will be interested in. 06:11 Update the documentation whenever there is a change. 08:48 Employees need to be continuously prepared for inspections. 11:58 You need to have a dedicated Inspection Manual. 16:25 What is the expectation in terms of control of the inspection readiness program? Join us at solabs-podcast@solabs.com Reach out to Caroline at cguayadam@skillpadcompliance.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 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. 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. 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 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!

Welcome to 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 episode features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recommendations to keep it high. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021. Key Takeaways 00:49 Introducing today's guest: Steve Gens, here to discuss Data Quality with us 02:10 Defining Data Quality? 04:00 What happens when the confidence in the data quality is low? 05:48 Steve provides some recommendations related to Data Quality. 10:30 How does Data Quality bring Quality and Regulatory together? 13:26 what are some services Gens & Associates offer related to this topic? Reach out to us at solabs-podcast@solabs.com

Welcome to 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 episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today's episode is good machine learning practices for the medical devices industry. Ben discusses some good machine learning practices (GMLP) and discusses the importance of standardizing those across the industry over time. Key Takeaways 01:00 Today's topic is good machine learning practices for the medical devices industry 01:20 Introducing today's guest: Ben Locwin 03:30 Ben introduces good machine learning practice guiding principles 06:43 How quickly will there be a set standardized framework for good machine learning practices (GMLP)? 11:10 Why this topic matters a lot 12:15 Will new competencies need to be developed for understanding the regulations and techniques in the field of machine learning? 14:36 Thank you to our guests and listeners!

Welcome to 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! In today's episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021. Our guest today is Katherine Yang-Iott. She is a consultant and analyst for Gens and Associates and the study lead for the firm's first Quality-focused benchmark. She's had 2 decades of experience as a scientist and researcher. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021. Key Takeaways 01:32 Introducing today's guest: Katherine Yang-Iott, an Analyst at Gens & Associates 03:07 Katherine introduces Gens & Associates and the context of this study 06:07 What were the key findings of this survey? 08:50 What is a QMS in the perspective of Katherine 11:12 What was the goal of the study in terms of information produced? 14:20 How the pandemic has increased companies' focus on supplier management 20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today 21:20 Philippe shares his thoughts on the benchmark's key learnings 22:57 What are the next steps for G&A in the world of quality? 25:15 Mandy thanks our guest and invites listeners to share their feedback