|Inefficient Batch Records Processes|
Batch operations conducted manually are inherently slow, cumbersome, and error prone. As regulations get more complicated, EBR systems become exponentially larger and more complex, taking more time to prepare and review. Common snags to manual batch operations include: incorrect data entry, failure to recognize out-of-specification entries, missing signatures, filling out incorrect forms, sending forms to the wrong recipient, and forms left incomplete.
|Efficient Process |
Electronic batch records software, developed by MasterControl, performs data integrity checks, automates calculations, and enforces required actions such as the initiation of an unplanned deviation. Automated routing ensures that all steps are carried out in sequence and that no signatures are missing, ever.
Physically tracking logs, test results, and other records from different departments is time consuming and can effect electronic batch record systems negatively. A manual process makes it almost impossible to avoid bottlenecks, a serious problem in case of a need to identify defective batches.
MasterControl's EBR software tracks all routing information and data entered into the electronic 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-electronic batch record system, data may be kept in different repositories that are disconnected - making reporting, trending, and analysis difficult.
|Connected EBR System Processes|
MasterControl EBR software solutions are part of the MasterControl integrated suite, allowing connectivity with other applications that control different 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.