EBR System - Electronic Batch Records

Automated EBR System Facilitates Compliance with FDA CGMP Requirements

For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Batch records, required under the FDA's Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling of every significant 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.

How can the MasterControl Electronic Batch Records™ EBR System Benefit You?

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 EBR management system addresses some of the major challenges that companies face in their batch record systems.

EBR System Challenges		MasterControl Electronic Batch Records™ EBR System Solution
Inefficient Batch Records Processes Batch operations conducted manually are inherently slow, cumbersome, and error-prone.		Efficient Process MasterControl automates 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.
Poor Tracking 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.		Automatic Tracking MasterControl 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 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.

 

Summary of Features

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.

• Framework for Master Recipes and Control Recipes: This automated EBR 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).

• Best-Practice Forms and Process : 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 EBR 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.

• Integrated with the Deviation Process: 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 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?.

• Form-to-Form Launching: 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.

• Analytics Reporting Tool: The MasterControl EBR system 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.

Compliant System: As with all software developed by MasterControl, the EBR management solution is fully compliant with 21 CFR Part 11. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval and password expiration, encryption, and certification.