EBR Software Systems - Electronic Batch Records

Automate EBR Systems with MasterControl Electronic Batch Records Software Systems to Ensure Compliance with FDA CGMP Requirements

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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How Can the MasterControl Electronic Batch Records™ (EBR) System Benefit You?

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.

Efficient Process

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.

Poor Tracking

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.

Automatic Tracking

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.

Disconnected Processes

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.

Features and Benefits of the MasterControl EBR Software System

MasterControl Process is the ideal platform for automating and optimizing management of batch records.

  • Complete Data Capture: All user entries are captured, electronically stored, and available for reporting in the EBR software. This includes loading of external files, making them part of the batch record.
  • Data Integrity Checks: Each field can run automatic checks to ensure that the data entered is in the correct format. Missing data, incorrect date formats or incorrect units of measure will never be a problem with MasterControl's EBR software.
  • Automated Calculations: Calculation logic ensures that each data item only has to be entered once and can feed into calculations such as yield calculations or recipe amount calculations. Never worry about accuracy of calculations again.
  • Performer/Witness Signoff: Each signature point can be configured for a single signature or Performer/Witness signatures within an electronic batch record systems. Performer/Witness signature points allow two users to submit their signatures from a single signoff window.
  • Parallel and Sequential Processing: Processing steps can be set up in a combination of sequential and parallel units.
  • Integrates with Deviations: Every manufacturing process needs a mechanism to deviate from the prescribed procedure, but controls must be in place to ensure that a deviation is acceptable. MasterControl's electronic batch records software seamlessly integrates the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process. MasterControl's EBR and Deviations solutions also link to other quality management modules such as MasterControl Nonconformance and MasterControl CAPA.
  • Analytics Reporting Tool: This built-in tool of an electronic batch records system comes with a standard set of pre-configured reports that can be customized by the user. Production records can be trended and analyzed by product, recipe, process stage, etc. These data-mining capabilities provide important insights into overall production activities such as turnaround, quality issue rates, etc.
  • Compliant System: As with all EBR software developed by MasterControl, the solution is fully compliant with 21 CFR Part 11 regulations, providing time-stamped audit trails, reporting, and electronic signature capabilities. Security features include dual passwords for document approval as well as password expiration, encryption, and certification.
  • Unparalleled Validation: MasterControl considers validation an integral part of solutions for FDA-regulated customers. MasterControl's revolutionary approach to validation dramatically cuts the time, effort, and cost of validation, making it easier to validate future upgrades.

For More Information on EBR Software Systems

To learn more about MasterControl's electronic batch records software systems, please contact a MasterControl representative.