For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Electronic batch records systems, required by FDA Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.
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MasterControl's electronic batch records system contains all the tools you need to create your electronic batch record forms, meeting all the requirements of Part 11. Our experienced process consultants will lead you through project scoping, requirements gathering, implementation, testing, validation, and go-live activities to deliver a EBR software solution that truly meets your organization's needs.
Here's how the MasterControl EBR software addresses some of the major challenges that companies face in their batch record systems.
EBR Systems Challenge
Electronic Batch Records™ Software Solution
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.
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.
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.