Stage 10: Lifecycle Management

In accordance with ICH Q12, Stage 10 covers the post-adoption management of digital tools. Once deployed, models should be subject to ongoing performance monitoring to detect drift, data changes, or loss of fitness for the approved context of use, with oversight embedded within the pharmaceutical quality system. Changes, including continuous improvement such as model updates or retraining, should be managed through formal change control, with re-verification/validation or regulatory engagement applied proportionately based on risk.

Furthermore, at this stage any planned model decommissioning should be carried out. This aims to ensure that tools which are no longer fit for purpose are formally retired, with appropriate documentation, traceability, and replacement controls in place. Together, these activities support sustained regulatory confidence and continued protection of product quality and patient safety over the full operational lifetime of digital tools