BRIMS – Batch Record Issuance Management Software

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• Audit trail for document superseding or outdated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.