Batch Record Issuance Management

BRIMS– Batch Record Issuance Manufacturing System

Batch Record Issuance management is used for Life science organization’s manufacturing processes are ought to be assets but not liabilities. Although it’s sure unintentional, too many companies treat the batch records like liabilities by using existing manual systems that are cumbersome, very slow and out of date.

Specifically, organizations in Pharma industry have been traditionally using paper to maintain Batch Records like Batch Manufacturing Records, Batch Packing Records, process and equipment templates, etc. in order to comply with the requirements of regulatory standards.

Errors and omissions in batch operations are inevitable and require constant recheck while executing the process, however, this manual operations wastes money and slows time to market. Manual data entry from the form to form creates lag time between departments and hinders general production processes.

Few of the common problems that frequently delay manual batch operations include:

  • Inappropriate data entry
  • Photocopy Access leads to misuse
  • Difficult to maintain 24X7 IP QA Team
  • Missing signatures
  • Filling out incorrect forms
  • Sending the wrong form to the erroneous person
  • Forms left incomplete etc.

AmpleLogic introduces the Batch Records Issuance Management System (BRIMS) platform to manage the Batch Records in the most efficient and effective manner.

AmpleLogic Batch Manufacturing Record Issuance Process(BMR)

AmpleLogic’s automated process Batch Record Issuance Management System (BIMS) – A 21 CFR Part 11 Compliant solution with a blend of Document Management and an Issuance Management helping Pharma Organizations in achieving good manufacturing practices (GMPs) at production facilities.

AmpleLogic Pharmaceutical BIRMS software – a valuable information technology tool for organizing, automating and controlling of BRs in an industry where Batch Manufacturing takes place and meticulous records are to be maintained, under strict compliance to regulations. The system provides an innovative automation solution right from the systematic and structured organization of documents to fully automated on-line product documentation.

  • The only player in the market with full-fledged Batch Issuance Software Implemented at 7 FDA approved Plants
  • 18 of the World’s Leading Pharma companies Batch #’s Pre-exists in our solution
  • Separate Solutions Formulations and API’s (Chemicals) to simplify Business User’s Job

Batch Issuance Software automates batch and continuous process administration, making standard operating procedures available, where there is no need for paper printouts, logbooks, or binders. With validated procedure built within the system, manual calculations and other manual tasks are eliminated. Few of the distinctive features of BIMS are-

  • Auto Batch # issuance with defined workflows
  • Prints control with privileged access restrictions
  • Audit Trail for document superseding or obsolescence
  • Owns a proprietary PDF component that allows workflow based prints
  • The complete batch process is predefined with all possible negative Scenarios
  • Not limited to Master Copy, also supports the issuance of raw data sheets, analytical sheets, and checklists

By leveraging Batch Manufacturing and Packing Issuance software, pharmaceutical companies shall gain integrated compliant control of Batch Record process on a single platform. The solution helps to auto-generate the Batch Nos. and printing them in all the Batch Manufacturing Record and Checklist. While the platform not only generates the Batch numbers automatically but also tracks the applicants who requested for BMR/BPR and who has approved the issuance of the document.

Key Features of Batch Record Issuance Management System

With hands-on experience in Batch Record Issuance, AmpleLogic continuous to be completely aware of Pharma specific compliance, security, internal processes, tools, and dynamics that play a critical role in successfully leveraging the capabilities of a strategic partner.

  • Uploads the scanned batch master copy documents and publish
  • Tracks the document versioning by superseding the previous versions
  • Print request initiation and approval
  • Auto-generation of destruction notes and workflow for the approval process
  • Allows the batch request on published batch master copies
  • Controls print copies with batch #, copy #, printed by and printed date
  • Archival of superseded or obsolete documents

Advantages with Batch Auto Issuance Process

  • Eliminates costly paperwork errors, speeds up information distribution and collaboration, and enables strategies for improving quality and efficiency
  • Reduced inventories
  • Improves product release quality
  • Automation at no cost of Process Change
  • Realizes over 50% time savings in data capture, document preparation, and QA data review
  • Makes it easier for Life Science companies to access and track batch records, model and change complex processes, and speed time-to-market.
  • Customer Satisfaction with Process Transparency and Regulatory Compliance results in more business
  • Facilitates organizing and controlling the individual template of processes, equipment operating
Our Batch Record Issuance 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.