For pharmaceutical, medical device, and manufacturing companies, accountability is an important component of quality management - and FDA and ISO compliance. Electronic batch records demonstrate accountability by providing proof of proper handling of every significant step in the production of each batch of a product. In addition, FDA regulated companies that execute and document batch records electronically must comply with the FDA's 21 CFR Part 11 requirements and good manufacturing practices.
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MasterControl Electronic Batch Records, designed based on the instrumentation, systems and Automation Society's S88 model (ISA-S88 or S88), is a powerful EBR management solution for automating and controlling batch processes. This automated EBR system will help ensure GMP compliance and increase efficiency in creating and managing master recipes and control recipes. For manufacturers automating their paper-based batch record systems for the first time, MasterControl meets all software-related requirements of Part 11.
Here's how the MasterControl electronic batch records management system addresses some of the major challenges that companies face in their batch record systems.
Electronic Batch Record Challenges
Electronic Batch Records™ Software
Inefficient Batch Records Processes
Batch operations conducted manually are inherently slow, cumbersome, and error-prone.
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.
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.
The MasterControl EBR management system is an ideal solution for automating and optimizing management of batch records. Below is a summary of its key features.
Learn how MasterControl helps manufacturing companies with electronic batch records by contacting MasterControl representative today.