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Manufacturing

Electronic Batch Record (EBR) Software Systems

Ensure EBR Compliance by Digitizing and Integrating Your Processes

For pharmaceutical companies, accountability is an important part of quality management and FDA compliance. Batch production records and other types of manufacturing documentation demonstrate accountability by providing the proof of proper handling for every step in producing each batch of a drug product, which is required by FDA Current Good Manufacturing Practice (CGMP) regulations. Manufacturers that manage their batch records electronically must also comply with 21 CFR Part 11 requirements.

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How Can MasterControl EBR Benefit You?

MasterControl’s electronic batch records system contains everything you need to create complete and compliant batch records. With its simple configuration and robust functionality, MasterControl EBR meets the unique and changing needs of your company now and in the future.

Challenge

MasterControl Solution

Inefficient Processes

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.

Streamlined Processes

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.

Poor Tracking

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.

Automatic Tracking

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.

Disconnected Data

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.

Integrated Data

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.

Features and Benefits of the MasterControl EBR Software System

MasterControl is the ideal platform for automating and optimizing batch record management.

  • Complete Data Capture All user entries are digitally captured, stored and easily accessible for reporting in the EBR software. Files from other systems and in different formats can also be loaded and included as part of the batch record, enabling true paperless production.
  • In-Line Quality Events From deviations and out of specifications to complaints and nonconformances, MasterControl EBR integrates quality directly in line with manufacturing for seamless and timely quality event handling and documentation.
  • Data Integrity Checks Each field can be configured to perform automatic checks to ensure that required data is entered in the correct format. Missing data, incorrect date formats, and incorrect units of measure are eliminated, and any out-of-specification data can be flagged for review by exception.
  • Analytics Reporting MasterControl Analytics can be configured to trend and analyze production records by parameters such as product, recipe and process stage. These data-mining capabilities provide important insights into overall production performance, including turnaround, scrap rates, on-time ship and operator productivity.
  • Automated Calculations Built-in calculation logic ensures that each piece of data only has to be entered once and can feed into calculations such as yields or recipe amounts.
  • Compliant System As with all MasterControl software, the EBR solution is fully compliant with 21 CFR Part 11, providing time-stamped audit trails, reporting, and electronic signature capabilities. It also delivers security features that meet the latest industry requirements.
  • Performer/Witness Signoff MasterControl EBR can accommodate performer and witness signatures in each field. It allows users to submit their signatures in real time from a single interface that can be accessed by multiple devices simultaneously.
  • Risk-Based Validation MasterControl’s Validation Excellence (Vx) methodology is a revolutionary approach that dramatically cuts the time, effort and cost of validation and makes it easier to validate software changes and upgrades.
  • Configurable WorkflowsWith the patent-pending Master Record Template Builder, production and processing workflows can be set up in any combination of parallel and sequential steps, including required dependencies. The latest version of related SOPs and WIs can also be linked to the respective workflow step, and the system can automatically verify that workers are up to date on required training.