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.
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.
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.
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.
This automated EBR system is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes. 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.
This automated electronic batch records solution creates a flexible framework to model a wide range of manufacturing processes in accordance with the S88 model for electronic batch records. It can handle a mix of parallel and sequential processing steps or unit procedures under the same recipe. The system helps ensure the capture of all data critical to GMP compliance in the following documents:
- Master Recipes (the documents that outline the details of a manufacturing process).
- Control Recipes (authorized copies of the currently effective Master Recipe that governs an individual manufacturing run).
MasterControl's automated EBR system provides a set of four pre-configured, multi-page forms that instruct users on the manufacturing steps and allows them to record all relevant data. Each step is electronically signed by a performer and a witness, in accordance with industry-standard documentation practice. This electronic batch records management solution helps enforce processes involving serial steps by requiring users to complete recording and verification of information before moving on to the next step.
Every manufacturing process needs a mechanism to deviate from the prescribed procedure, but controls have to be in place to ensure that a deviation is acceptable. MasterControl Deviations™ can be integrated to electronic batch records that seamlessly integrate the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process. Deviations also serve as the link to other MasterControl quality management modules such as MasterControl Nonconformance and MasterControl CAPA.
A Control Recipe can be created through form-to-form launching from a Master Recipe form. This allows relevant data to be transferred automatically from one form to the other, linking the forms and reducing manual data entry. By the same mechanism, a Deviation form can be launched from a Control Recipe form, triggering a separate quality review process.
The MasterControl electronic batch records has a built-in analytics tool that comes with a standard set of pre-configured reports that can be adjusted and customized by the end user. Production records can be trended and analyzed by product, recipe, etc. These "data-mining" capabilities can give important insights into overall production activities such as turnaround, quality issue rates, etc.
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