TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
About this episode
Yeime Martich discusses the importance of quality culture and logistics in audit readiness for life science companies.
Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize. Yeime discusses why "minimally compliant" is a discipline rather than a shortcut, how leadership shapes quality culture through what they ask about, fund, and tolerate, and why the strongest signal of a healthy quality system is when people come to quality voluntarily to report problems. A few of Yeime's key takeaways: Inspection readiness is the natural output of a healthy quality system, not something you build in the weeks before an audit "Minimally compliant" means meeting the regulatory intent without overcommitting in your procedures to things your team can't actually follow Quality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for example Leadership shapes culture through what they ask about, what they fund, and what they tolerate The…
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