Establish Governance Before You Need It As AI tools become embedded in regulated workflows, questions of ownership and accountability become unavoidable. Who approves updates to a model that influences a regulated decision? What happens when a model is retired? How are changes shared with the people relying on it? These questions are far easier to answer before a problem surfaces than after. Involve your regulatory affairs team early. Heads Up There’s a lot of software involved in developing confidence indicators and connecting the model to internal systems. Yahara can help. Reach out to us for assistance. Monitor Performance After Deployment A model that was accurate at launch won't necessarily stay that way. Processes evolve, reagent lots change, and the data the model encounters in production will gradually diverge from what it was trained on. Define a performance baseline at deployment, track against it over time, and establish the conditions that would trigger a retraining cycle. A model with no monitoring plan is a model on a slow path toward silent failure. Connect to The Systems Your Team Already Uses For a model to become part of how a lab operates, its outputs need to land somewhere familiar and actionable — inside your LIMS, your ELN, your existing review workflow. If using the model requires someone to leave the system they're already working in, most people won't do it consistently. Integration is crucial for adoption. 3 4 5 22
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