Electronic Batch Record

Manual batch record execution is inherently slow and error-prone, and often leads to issues such as data entry errors, out-of-specification entries, missing signatures and incomplete forms. As regulations evolve, batch records become more complex and require more time to prepare and review.

MasterControl’s electronic batch records software performs data integrity checks, automates calculations and enforces required actions such as initiating unplanned deviations. Automated routing ensures that all steps are carried out in sequence and that no data or signatures are missing, ever.

Physically tracking logs, test results and other records from different departments is time-consuming and can negatively affect batch record system efficiency. These inevitable bottlenecks are a serious problem, particularly during a recall.

MasterControl EBR software tracks all routing information and entered data, allowing managers and other stakeholders to follow the overall process, identify bottlenecks and understand the sequence of events during processing.

In a paper-based or partially electronic batch record system, data may be kept in different repositories that are disconnected – making reporting, trending and analysis difficult.

MasterControl EBR fully integrates with other enterprise applications and quality processes. Production data can be correlated with deviations, material nonconformances and customer complaints. Through its robust analytics functionality, MasterControl leverages all data collected by the system for use in continuous quality improvement.