eBMR

Pharmaceutical Electronic Batch Manufacturing Record Management (eBMR) Software

In the Life Sciences Industry Batch Record provides proof that an organization properly handles and records all critical steps to produce each batch of a product.  Currently the recording is done in manual Batch manufacturing records in the GMP Environments

The organization need to keep check on the following areas in order to avoid data Integrity issues

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

These manual checks are tedious as the number of batches manufactured in Formulations units range from 20 to 200 batches per day and in API’s the numbers are higher.

Implementing an electronic batch record system helps organizations to improve data integrity and accuracy. It can streamline processes and increase operational efficiency which positively impacts the bottom line.

AmpleLogic eBMR is a typical manufacturing Execution system (MES), designed to meet the needs of the Pharmaceutical and Bio technology Industry. Our Electronic batch recording software helps in recording the detailed manufacturing steps specific to the product. It also optimizes your processes through introduction of electronic work instructions, process check points, mapping process activities and effective exception handling. The software delivers paperless manufacturing by replacing paper batch records, batch approval and release process through an online environment.

AmpleLogic Electronic Batch Record System is built on LOW CODE PLATFORM with a modular design which facilitates the breaking down of the entire pharmaceutical manufacturing process into small components. Users can drag and drop processes (like granulation, compression, coating, packaging etc.) and select process specific activities(like Punch Specifications, Milling, Sieving, Average mass of coating, De Blistering etc) that shall be carried out for every batch to be executed.

The Dispensing module allows users to define the Raw materials and their weight-age calculations.

Our packing components allows users to manage the Bi-layer, and Co-pack scenarios.

To further improve performance and reinforce authenticity of steps during the manufacturing process AmpleLogic eBMR can be easily integrated with instruments and equipment. This is how AmpleLogice BMR solution provides real time visibility and traceability into manufacturing operations and processes.

It is a scalable solution, which may be used by itself, integrated with existing systems or integrated as a turnkey solution. Utilizing our Low Code platform, we provide businesses with an integrated environment that obtains information from ERP, LIMS, Quality Management System (QMS), Document Management System (DMS), Learning Management System (LMS), Electronic Log Book (eLogs) and other MES control systems.

eBMR Software Key Features

  • Electronic batch record module that provides routing, review and approval of manufacturing records
  • Batch Scheduling that provides real time production schedules
  • Electronic instructions to enforce workers follow established processes and procedures
  • Line clearance for Dispensing raw materials and packing materials
  • Will allow qualified and authorized personnel to use the software
  • Exception handling module to spot deviations during the manufacturing processes
  • Electronic signatures and audit trails for all modules of production process and operation activities in the system.
  • Role based permission at different levels
  • Can track the sequence of actions with barcode or QR code.
  • Automated email notifications, reminders and escalations for each stage of approving batch record and each activity defined for the users.
  • User Activity recorded with date and time stamp throughout the workflow.
  • A content repository that provides controlled access to executed batch manufacturing record document.
  • Product Label management
  • Integration with equipment and record events like usage, cleaning and maintenance.
  • Integration with weighing and dispensing instruments to ensure correct measurement of the materials processed.
  • Integration with active directory and bio-metric for authentication
  • Trending graphical reports and batch certificates

AmpleLogic Electronic Batch Management Record System is a uniquely designed software, created to comply with Good Manufacturing Practices and relevant Documentation in Pharmaceutical, Life Sciences, Biotech, and other manufacturing Industries.

Electronic Batch Records (EBRs) Software benefits

  • Reduces Batch Review Cycle Times
  • Enforces the implementation of GMP practices
  • Adherence to standard operating procedures (SOPs)
  • Improves data integrity
  • Provides real-time traceability
  • Enhances accuracy, productivity, and consistency
  • Improves decision making

Our electronic Batch Records Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH

Other industries that can take advantage of Batch Records Automation Software

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