Q: Does POMSnet comply with 21 CFR Part 11?A: 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.
Q: Does POMSnet integrate with other systems?A: POMSnet Integration Builder provides integration with enterprise resource planning (ERP) systems, laboratory information management systems (LIMS), Quality Management and Document control systems. The synchronization of plant floor data with these other systems makes POMSnet extremely valuable, not only as a system for managing the plant, but also for providing information to planners and quality control for smarter, faster decision-making. POMSnet has standard interfaces to many ERP systems that can be rapidly deployed. The POMSnet Integration Builder also supports web services to make integration in a web service-oriented architecture easy.
Q: How is “time to market” affected by POMSnet?A: “Time to market” is accelerated by the POMSnet Enterprise Specification Management module. The POMSnet Enterprise Specification Management module removes barriers between product development, manufacturing and operations, enabling collaborative development and deployment of product recipes and manufacturing specifications. It also capitalizes on intellectual assets by capturing the rules for product scale-up, rollout and update in modular reusable specifications.