Electronic Batch Record (EBMR) Software for Pharmaceutical Manufacturing

In the Life Sciences Industry, a batch record confirms that an organization manages and documents all important procedures involved in producing a batch of a product properly. Current batch manufacturing records in GMP environments use manual recording methods.

Electronic Batch Record, eBMR

To avoid data integrity risks, the company must keep a close eye on the following areas:

  • Issuance and reconciliation of Batch Records
  • Employee training records on their qualifications
  • Verification of Logbook data against the Batch records information
  • Employee clock-in and clock-out times

These manual tests are time-consuming because the number of batches manufactured in Formulations units ranges from 20 to 200 batches each day, and the numbers are even greater in APIs.

By implementing an Electronic Batch Record System (eBMR), organizations can enhance the integrity and accuracy of their data. It has the potential to streamline procedures and boost operational efficiency, which has a beneficial effect on the bottom line.

AmpleLogic eBMR is a standard manufacturing execution system (MES) that was developed specifically for the Pharmaceutical and Biotechnology industries. Our Electronic Batch Recording Software assists in the thorough recording of manufacturing processes relevant to a product. 

By using electronic work instructions, process checkpoints, process mapping, and effective exception handling, it helps you optimize your processes. Paper batch records, batch approval, and batch release processes are replaced by an online environment using EBR Software, resulting in paperless manufacturing.

AmpleLogic Electronic Batch Record System is based on a LOW CODE and NO CODE (LCNC) PLATFORM with a modular design that enables the process of pharmaceutical manufacturers to be broken down into small components. Each batch can have its own specific set of activities that must be completed for each batch to be accomplished (such as Punch Specifications) and drag-and-drop processes can be used to do this. Users can also select process-specific activities (such as average coating mass, de-blistering, and milling) for each batch to be executed.

Users can specify raw materials and weight-age calculations in the dispensing module. Our packing components enable customers to manage scenarios involving bi-layer and co-packing.

AmpleLogic eBMR Software can be easily integrated with instruments and equipment to enhance performance and ensure the credibility of manufacturing processes. This is how the AmpleLogic eBMR Solution maintains real-time visibility and traceability of industrial activities and processes.

It is a flexible solution that may be utilized on its own, or as part of a turnkey solution that integrates with other systems. We provide enterprises with an integrated environment that collects data from ERP, LIMS, Quality Management System (QMS), Document Management System (DMS), Learning Management System (LMS), Electronic Logbook (eLogs), and other MES control systems through our Low Code Platform

Key Features of AmpleLogic eBMR Software

  • Module for electronic batch records that allows manufacturing records to be routed, reviewed, and approved
  • Scheduling batches in real-time to offer production plans
  • Electronic instructions are used to ensure that employees adhere to defined processes and procedures.
  • Line clearance for distributing raw materials and packing materials.
  • Allows the software to be used by individuals who are both qualified and authorized.
  • Exception handling module for detecting irregularities in manufacturing processes.
  • Electronic signatures and audit trails are provided for all modules of the manufacturing process and system operation activities.
  • Different levels of permission according to role.
  • Barcodes and QR codes can be used to trace the progression of an action. This eBMR Software will be able to generate the Barcodes with respective to Room, Equipment, material, and product
  • Notifications and escalation by automated email for each stage of batch record approval and each activity designated for the users.
  • Throughout the procedure, user activity is logged with a date and time stamp.
  • Access to batch production records can be restricted via a content repository.
  • Product label management.
  • Integration with PLCs, equipment, as well as the recording of events such as usage, cleaning, and maintenance.
  • Integration with weighing and dispensing tools ensures accurate material measurement.
  • Authentication via Active Directory integration and biometrics.
  • Graphical reports on the latest trends and batch certificates

AmpleLogic Electronic Batch Record Software is a one-of-a-kind software application designed to ensure compliance with Good Manufacturing Practices and relevant documentation in the pharmaceutical, life sciences, biotech, and other manufacturing industries.

Benefits of the Electronic Batch Records (eBMR) Software

Reduced Cost of Compliance
  • Automating quality assurance operations and reporting features in the eBMR software will decrease the effort required to research product deviations and ensures that GMP procedures are followed.
Increased Productivity
  • Electronic exchange of batch records decreases the amount of time spent collecting the various components of the batch record from different departments and speeds up the Batch Review process
Improved accuracy and consistency of batch records
  • The structure provided by the electronic batch records will help to decrease errors , which in turn will decrease the time spent by quality assurance in the the review of these records and enhances decision-making process.
Increased speed of product changes and product introductions
  • Use of electronic batch recording system in the development process will lead to greater efficiencies in a new drug application.
Error Reduction in documentation
  • Eliminate calculation errors and ensures the data integrity
Time Reduction in review cycle
  • Reducing the time required to identify, review or approve and resolve process exceptions and collect the real-time information from different sources.
Efficiency Improvements
  • Material checks, weight verifications and product checks as well as allows for real-time traceability.

Additionally, our Electronic Batch Records Software will adhere to TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH electronic record requirements.

Other industries that can take advantage of Batch Records Automation Software

  • Biologics
  • Medical Devices
  • Contract Development and Manufacturing Organization (CDMO)
  • Chemical Industry
  • Contract Manufacturing
  • Generics
  • General Manufacturing
  • Contract Research Organization (CRO)
  • Food & Beverages

To learn more about how AmpleLogic’s electronic batch manufacturing record (eBMR) can benefit your company, please get in touch with us.

Electronic Batch Record (EBMR) Software for Pharmaceutical Manufacturing

In the Life Sciences Industry, a batch record confirms that an organization manages and documents all important procedures involved in producing a batch of a product properly. Current batch manufacturing records in GMP environments use manual recording methods.

ebmr

To avoid data integrity risks, the company must keep a close eye on the following areas:

  • Issuance and reconciliation of Batch Records
  • Employee training records on their qualifications
  • Verification of Logbook data against the Batch records information
  • Employee clock-in and clock-out times

These manual tests are time-consuming because the number of batches manufactured in Formulations units ranges from 20 to 200 batches each day, and the numbers are even greater in APIs.

By implementing an Electronic Batch Record System (eBMR), organizations can enhance the integrity and accuracy of their data. It has the potential to streamline procedures and boost operational efficiency, which has a beneficial effect on the bottom line.

AmpleLogic eBMR is a standard manufacturing execution system (MES) that was developed specifically for the Pharmaceutical and Biotechnology industries. Our Electronic Batch Recording Software assists in the thorough recording of manufacturing processes relevant to a product. 

By using electronic work instructions, process checkpoints, process mapping, and effective exception handling, it helps you optimize your processes. Paper batch records, batch approval, and batch release processes are replaced by an online environment using EBR Software, resulting in paperless manufacturing.

AmpleLogic Electronic Batch Record System is based on a LOW CODE PLATFORM with a modular design that enables the process of pharmaceutical manufacturers to be broken down into small components. Each batch can have its own specific set of activities that must be completed for each batch to be accomplished (such as Punch Specifications) and drag-and-drop processes can be used to do this. Users can also select process-specific activities (such as average coating mass, de-blistering, and milling) for each batch to be executed.

Users can specify raw materials and weight-age calculations in the dispensing module. Our packing components enable customers to manage scenarios involving bi-layer and co-packing.

AmpleLogic eBMR Software can be easily integrated with instruments and equipment to enhance performance and ensure the credibility of manufacturing processes. This is how the AmpleLogic eBMR Solution maintains real-time visibility and traceability of industrial activities and processes.

It is a flexible solution that may be utilized on its own, or as part of a turnkey solution that integrates with other systems. We provide enterprises with an integrated environment that collects data from ERP, LIMS, Quality Management System (QMS), Document Management System (DMS), Learning Management System (LMS), Electronic Logbook (eLogs), and other MES control systems through our Low Code Platform

Key Features of AmpleLogic eBMR Software

  • Module for electronic batch records that allows manufacturing records to be routed, reviewed, and approved
  • Scheduling batches in real-time to offer production plans
  • Electronic instructions are used to ensure that employees adhere to defined processes and procedures.
  • Line clearance for distributing raw materials and packing materials.
  • Allows the software to be used by individuals who are both qualified and authorized.
  • Exception handling module for detecting irregularities in manufacturing processes.
  • Electronic signatures and audit trails are provided for all modules of the manufacturing process and system operation activities.
  • Different levels of permission according to role.
  • Barcodes and QR codes can be used to trace the progression of an action. This eBMR Software will be able to generate the Barcodes with respective to Room, Equipment, material, and product
  • Notifications and escalation by automated email for each stage of batch record approval and each activity designated for the users.
  • Throughout the procedure, user activity is logged with a date and time stamp.
  • Access to batch production records can be restricted via a content repository.
  • Product label management.
  • Integration with PLCs, equipment, as well as the recording of events such as usage, cleaning, and maintenance.
  • Integration with weighing and dispensing tools ensures accurate material measurement.
  • Authentication via Active Directory integration and biometrics.
  • Graphical reports on the latest trends and batch certificates

AmpleLogic Electronic Batch Record Software is a one-of-a-kind software application designed to ensure compliance with Good Manufacturing Practices and relevant documentation in the pharmaceutical, life sciences, biotech, and other manufacturing industries.

Benefits of the Electronic Batch Records (eBMR) Software

Reduced Cost of Compliance
  • Automating quality assurance operations and reporting features in the eBMR software will decrease the effort required to research product deviations and ensures that GMP procedures are followed.
Increased Productivity
  • Electronic exchange of batch records decreases the amount of time spent collecting the various components of the batch record from different departments and speeds up the Batch Review process
Improved accuracy and consistency of batch records
  • The structure provided by the electronic batch records will help to decrease errors , which in turn will decrease the time spent by quality assurance in the the review of these records and enhances decision-making process.
Increased speed of product changes and product introductions
  • Use of electronic batch recording system in the development process will lead to greater efficiencies in a new drug application.
Error Reduction in documentation
  • Eliminate calculation errors and ensures the data integrity
Time Reduction in review cycle
  • Reducing the time required to identify, review or approve and resolve process exceptions and collect the real-time information from different sources.
Efficiency Improvements
  • Material checks, weight verifications and product checks as well as allows for real-time traceability.

Additionally, our Electronic Batch Records Software will adhere to TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH electronic record requirements.

Other industries that can take advantage of Batch Records Automation Software

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages

To learn more about how AmpleLogic’s electronic batch manufacturing record (eBMR) can benefit your company, please get in touch with us.

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