Automating Quality

Automating Quality is an interview show about quality management and regulatory compliance in the life sciences, sponsored by Solabs. On the show, Solabs is described as a company that helps mid-sized life sciences organizations with an EQMS called Solabs QM10. Philippe hosts much of the recent run and introduces himself as its CEO. The cold opens say so plainly. The subjects are the everyday mechanics of a regulated quality system. Validation. Vendor qualification. Internal audits. Investigations. In 'Episode 63 - Qualification of Software Vendors with Masha Ivankovic', vendors are sorted by risk. Software that directly affects product quality, such as a system that controls temperature or humidity in a pharmaceutical process, ranks high. Business continuity and complexity count as well: custom builds rate higher than configurable tools, and off-the-shelf firmware rates lowest. The biotech conversation with Paul Michel is just as specific. It explains that the FDA divides oversight of biologics between two centers while EMEA and Health Canada do not, and it points to the ICH Q5 series for biologics. With Jim Ferguson the focus is self-inspection. Mature organizations have a quality culture, less mature ones push it down the list, and inspections tend to bring the difference out as observations and findings. The value-added quality episode with Ed Siurek argues for efficiency over investigations that drag on for weeks or months. It also recalls a time before ISO 13485, when ISO 9000 was the reference, and makes the point that good enough is not always the standard. The host bills 'Episode 60: Investigative Methods with Michael Tyo' as a follow-up to episode 59, though he says it also works on its own. It moves step by step, like a worked lesson. A fishbone analysis asks whether the work environment was too hot, too dark or too noisy. Then the five whys trace a rejected lot back to a contaminated raw material that was accepted on an identity test alone. Mandy and a co-host present an episode introduced as the first of a three-part series on AI in regulated industries. There, CSA is treated as a shift rather than a shortcut, and the talk covers intended use, risk rationale, keeping control over time and quality agreements with software vendors. Risk keeps coming back across these conversations: how to rank a vendor, how to justify a validation approach, how far to dig for a root cause. Episodes end by pointing to the show notes for guest contact details, and Philippe invites suggestions for future subjects. For a first listen, the vendor qualification and investigative methods episodes show the format at its most concrete.