Planning - Scheduling and Regulatory Compliance

You can also use the information your system gathers to improve quality and consistency and to meet regulatory requirements. In addition, system benefits include improvements in capacity and production by providing faster phase transition, reducing cycle times and optimizing equipment use. The Integrated Architecture includes a comprehensive data model that provides you with real-time process data and analysis. Using this analysis, you can identify a specific production cycle as the "golden batch," and compare subsequent batches of the same product even when equipment variations are present. This capability enables you to identify and respond to deviations from expected production parameters much earlier than is possible with post-batch quality analysis, resulting in more consistent quality product and less waste. Subsequent analyses can be used to identify a new batch as the "golden batch”.

The system can also interact with external production planning and scheduling functions to reduce errors and time delays, share equipment, personnel, or materials availability; update expected batch or production run completion times; and share projected resource availability. These functions can be local to the site, or at a business level, as with Oracle, Microsoft, or SAP ERP functions. Easily compare site, corporate, and customer standards for settings, formulations, and procedural functions with actual production.

You'll gain insight into your processing operations to improve product quality and consistency, and increase production throughput. To comply with regulatory requirements such as Food and Drug Administration (FDA) 21 CFR Part 11, or to enhance system security, you can record all operator actions and changes, alarm and event messages, and/or application-generated messages. And, for added security and quality traceability during manual operations and operator-initiated changes, you can require electronic signatures.