Batch Record Issuance Management Software (BRIMS)

AmpleLogic’s Automated Batch Record Issuance Management System (BRIMS) complies with 21 CFR Part 11. To help pharmaceutical companies attain high and seamless manufacturing standards (GMPs) and also maintain correct records of their manufacturing facilities, the system has a combination of Document Management and Issuance Management solutions.

AmpleLogic Pharmaceutical BIMS software is a web-based application designed to help with for managing, automating, and regulating BRs in organizations where Batch productions are a thing and records are carefully tracked under strict compliance with corporate norms and regulations. AmpleLogic’s unique solution is both inventive and automated, but beyond that, it also provides complete documentation, ranging from the systematic and organized organization of documents to fully automated online product documentation.

AmpleLogic Electronic Batch Record System allows users to set several sorts of reports such as Batch Reprint Report, BPR Traceability Report, Batch Summary Report, BMR Traceability Report, Batch Reconciliation Report, and many others. All of the reports are flexible and may be entirely customized to meet your specific needs.

  • Presently, we are the only one in the market with complete batch issuance software in place at seven FDA-approved facilities
  • Our solution is also used by 18 of the world’s most prominent pharmaceutical firms that have become a part of our clientele, all of which have given it high ratings and reviews
  • Separate solutions are run by the system Formulations and APIs (Chemicals) that make the user’s work easier

Standard operating procedures are provided by the Batch Record Issuance Software through its automation of batches and consistent process management. ​As a result, the user does not need paper printouts, logbooks, or binders to administer the system. Finally, a proven inbuilt method embedded in the system eliminates the need for manual computations and other manual tasks.

The AmpleLogic Batch Record Issuance Management System (BRIMS) effectively fits the current manufacturing needs and procedures of the pharmaceutical, biotech, and life sciences industries.

Some of AmpleLogic BRIMS’s distinguishing features include:

  • It allows for automatic Batch issuance based on predefined workflows
  • Control overprinting with privileged access constraints
  • Audit trail for document superseding or outdated
  • It has a unique PDF component that enables workflow-based printing
  • All probable bad situations have been predefined and included in the entire batch process
  • In addition to the master copy, it also allows for the issue of raw data sheets, analytical sheets, and checklists

Pharmaceutical businesses now have unprecedented access to the Batch Record Process efficiently on a single platform as a result of the Batch Manufacturing and Packing Issuance software. Using this batch record issuance software solution, it is easy to automatically create and print batch numbers on Batch Manufacturing Records and checklists.

Important Features of the AmpleLogic Batch Record Issuance Management System

AmpleLogic has years of experience and research on Batch Record Issuance, and we have combed the market for things like Pharma Specific compliance, safety, internal processes, tools, and other important dynamics that are very important in keeping these industries afloat in a highly competitive market and making sure of their success.

Based on this study, the following characteristics have been carefully built into this system:

  • It uploads the master copy files of the scanned batch and aids in their publication
  • It monitors and manages document versioning and guarantees that the latest version surpasses prior versions
  • Initiation and authorization of print requests
  • Automated destruction notices and workflow creation to make the approval process easier
  • Allows batch requests to be made on published batch master copies
  • It handles the print copies and contains batch numbers, copy numbers, who printed the document, and the date it was produced
  • Documents that have been replaced or are no longer in use are archived

Benefits of the Batch Auto Issuance Process

  • It prevents costly and dangerous errors caused by paperwork or manual procedures. It also speeds up the dissemination of information and cooperation and assures quality and efficiency
  • Consistent adherence to 21 CFR Part 11, cGMP, GMP, MHRA, EU Annex 11, and other regulations
  • Realized inventories are significantly decreased
  • The workflow mechanism of AmpleLogic Batch Issuance Management Solution (BIMS) makes sure that the actions are executed in the correct order by the authorized personnel. All activities will be recorded with an electronic signature and time stamp
  • The final product’s quality is given the highest importance
  • The process is quick, automated, and modestly priced
  • Accuracy, document preparation, and QA data review are all facilitated by data collection
  • Life Science organizations may now access and monitor batch records more easily with AmpleLogic Batch Record Issuance Management Software. It also allows them to easily identify and modify complicated processes, which reduces the time it would take to get the product to the market
  • The transparency of processes and compliance with regulations ensures client satisfaction
  • It makes it easier to organize and regulate the individual template of processes and equipment operations

The AmpleLogic Batch Record Issuance Software conforms with Electronic Record Standards specified by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

18 clients have put their faith in AmpleLogic Batch Record Management Module. In 14 USFDA-approved facilities and four MHRA-approved units, our Batch Issuance Software recorded the issuance of 0.2 million master copies.

Please contact us for more information on how AmpleLogic Batch Record Issuance Management Software may benefit your company.

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