|Inefficient Batch Records Processes|
Batch operations conducted manually are inherently slow, cumbersome, and error-prone.
|Efficient Process |
MasterControl electronic batch records automate routing, follow-up, and escalation of batch records for more efficient process management. Pre-configured forms simplify data collection and help minimize errors common in manual data collection. The electronic in-box tracks all active tasks for a user and provides the tools to stay up-to-date. This automated EBR system is based on the S88 standard, providing an FDA-compliant framework to model a wide range of manufacturing processes.
Without an electronic batch records system, physically tracking logs, test results, and other records from different areas is time-consuming. A manual process makes it almost impossible to avoid bottlenecks, a serious problem in case of a need to identify defective batches.
MasterControl tracks all routing information and data entered into the electronic batch records form, allowing the batch coordinator to follow the overall process, identify bottlenecks, and understand the sequence of events during processing.
|Disconnected Processes |
Under a paper-based or a partially automated EBR system, data are kept in different repositories that are disconnected, making reporting, trending, and analysis difficult.
|Connected EBR System Processes|
This automated EBR system is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes. For example, production data can be correlated to deviations, material nonconformances, and customer complaints. Through its robust analytics capability, MasterControl leverages all data collected by the system for use in continuous quality improvement.