Does POMSnet comply with 21 CFR Part 11?
POMSnet complies with all the requirements of 21 CFR Part 11, and includes the generation of an electronic batch record (EBR) that is a complete 21 CFR Part 11 compliance record. The compliance record is an exact, unalterable representation of all events that took place during production—an audit trail that includes all operator actions, strikethroughs, signatures, data collected, deviations, and test results. During the execution of recipes, POMSnet EBR captures activity, events and information from recipe or worksheet execution that demonstrate compliance. A tamper-proof batch/device record is provided for compliance reporting, traceability, and analysis. In addition, by capturing all aspects of production in a unified history, the system provides a comprehensive chronicle of key performance indicators (KPI) as a demonstrable measure of productivity and quality.
