Author Archives: Ewald Amherd

Transforming Deviation Management

All biopharmaceutical companies espouse a belief in scientific, risk-based approaches. However, with respect to deviation management systems (DMSs), the industry is falling short of that promise. By and large, companies still use a small-molecule pharmaceutical compliance model that dates back to the 1980s, based on the strategy that all deviations are created equal and require 30-day closure. Most bioprocessors still hold to a default 30-day rule, even though there is no specific regulatory requirement for that time frame. Major or…