Batch Record Issuance Management

BRIMS – Batch Record Issuance Management Software

Pharmaceutical manufacturing companies rely heavily on Batch Record Issuance Management (BRIM). The reason for this is that before the process can begin, the organization must verify that it has accumulated sufficient assets, rather than liabilities; batch record issuance management is the instrument that aids in the distinction of the organization’s assets from its liabilities. This procedure can be laborious for some organizations, mostly since they rely on slow and mechanical manual processes.

Pharmaceutical companies that rely on paper for batch records like batch manufacturing records (BMR), batch packing records (BPR), process and equipment templates, and so on, have a tough time keeping track of their records in accordance with the statutory standards.

In the course of production, batch processes suffer mistakes and omissions, which are thoroughly reviewed and crosschecked for mistakes, and these errors are unavoidable. Manual processes are both time-consuming and expensive, which slows production and restricts information exchange between departments.

Among the typical issues that commonly cause manual batch processes to be delayed are

  • Correction of mistakes wastes time, paper, and other valuable resources
  • Due to the presence of similar data in several places, documentation could be time-consuming and redundant
  • There are chances of data entry being incorrect, improper, or repetitive 
  • Abuse of usage as a result of access to photocopy
  • The templates’ authenticity and update management
  • Because of its high mechanical nature, maintaining a consistent IP QA staff is very challenging
  • Loss of signatures
  • Completing forms wrongfully
  • Wrong distribution of forms within departments or between people
  • Not filling out all fields in forms, and so on

As a result of these issues, AmpleLogic has developed the Batch Records Issuance Management System (BRIMS) platform, which makes it easy to handle batch records.

AmpleLogic Batch Manufacturing Record (BMR) Issuance Process

AmpleLogic’s automated process Batch Record Issuance Management System (BIMS) 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.

Key Features of AmpleLogic Batch Record Issuance Management System

With years of experience and research on Batch Record Issuance, AmpleLogic have perused the market on subjects such as Pharma Specific compliance, security, internal processes, tools, and other major dynamics that play very cogent roles involved in sustaining these industries in a very competitive market and ensuring that they thrive. This system has been carefully designed with the following features based on this research:

  • Batch Record Issuance Manufacturing - Upload It uploads the scanned batch master copy documents and helps in publishing it
  • BMR - Batch Record Issuance ManufacturingTracks and maintains document versioning and ensures that it supersedes the previous versions
  • Batch Record Issuance Manufacturing - BRIMS Print request initiation and approval
  • Work Flow Process - Batch RecordsAuto-generation of destruction notes and workflow to ease the approval process
  • Batch Request - BRIMS Allows the batch request on published batch master copies
  • Print Control - Batch Issuance Controls print copies and includes batch number, copy number, who made the printout and date printed
  • Batch Records - AmpleLogicArchival of superseded or obsolete documents

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
AmpleLogic Batch Record Issuance Management Module trusted by 18 Customers. Our Batch Issuance Software recorded an issuance of 0.2 Million Master Copies in 14 USFDA Approved plants and 4 MHRA Approved Units.
Please contact us for more information on how AmpleLogic Batch Record Issuance Management Software may benefit your company.