BRIMS – Batch Record Issuance Management System
Batch Record Issuance Management plays a significant role in the manufacturing processes of a pharmaceutical manufacturing organizations. This is because in order for the process to commence, the organization ensures that it has garnered ample assets and not liabilities- the batch record issuance management is the tool that helps split the organization’s assets from its liabilities. Some organizations find this process tedious because they make use of manual processes that are very mechanical and slow.
Pharmaceutical industries that make use of paper to maintain Batch Records like Batch Manufacturing Records (BMR), Batch Packing Records (BPR), process and equipment templates, etc., find it extremely difficult keeping track of their industries records in accordance with the standards and requirements set by regulatory bodies.
Batch operations experience errors and omissions during the course of production and are carefully checked and crosschecked for errors and at that, these errors are inevitable. The manual operations are also costly and time consuming, stalls production and hinders free flow of information between departments
Few of the common problems that frequently delay manual batch operations include:
- Reconciliation of errors leads to wastage of time, paper and valuable resources.
- Laborious and repetitive documentation due to similar data appearing at many places
- Data entry can be incorrect, inappropriate or repeated.
- Misuse due to photocopy access.
- Integrity and version management of the templates
- Due to its highly mechanical nature, maintenance of round the clock IP QA team becomes extremely difficult.
- Missing signatures
- Filling out incorrect forms
- Errors in dispatching of forms within departments or personalities.
- Incomplete forms, etc.
To ease the above challenges and inconvenience, 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 (BMR) Issuance Process
AmpleLogic automated process Batch Record Issuance Management System (BIMS) is a 21 CFR Part 11 compliant solution. The system comes with a blend of Document Management and an Issuance Management solutions that is designed to aid pharmaceutical organizations in achieving top notch and stress-free manufacturing practices (GMPs) and also keeping accurate records in their production facilities.
In organizations where Batch productions take place and records are closely monitored under strict compliance to company rules and regulations, AmpleLogic Pharmaceutical BIMS software is designed to be a convenient technological tool for arranging, automating and controlling of BRs. AmpleLogic unique solution is not just innovative and automated, it also ensures thorough documentation that ranges from the systematic and structured organization of documents to fully automated on-line product documentation.
- We are currently the only player in the market with full-fledged batch issuance software implemented at 7 FDA approved plants.
- We also have 18 of the world’s renowned Pharma companies as clients of our solution with good appraisals and reviews about it.
- The system runs separate solutions Formulations and API’s (Chemicals) to simplify the user’s job.
Batch Record Issuance Software ensures standard operating procedures are made available by automating batch and continuous process administration. Hence, the user does not require paper printouts, logbooks or binders to facilitate administration. Lastly, it eliminates manual calculations and other manual tasks with the help of a validated procedure built within the system.
AmpleLogic Batch Record Issuance Management System (BRIMS) exactly meets the current Pharmaceutical, Biotech and Life Sciences industry manufacturing requirements and procedures.
Some of the unique attributes of AmpleLogic BRIMS includes
- Allows 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
With the aid of the Batch Manufacturing and Packing Issuance software, pharmaceutical companies are allowed unparalleled access to Batch Record Process efficiently on a single platform. With this software solution, Batch numbers on Batch Manufacturing Records and checklists are generated and printed easily and automatically. Furthermore, the system also tracks applicants requesting for a BMR/BPR or approving the issuance of the document
Key Features of 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:
Advantages with Batch Auto Issuance Process
- It removes costly and damaging errors made by paperwork or manual processes, hastens information dissemination and collaboration and ensures that quality and efficiency are guaranteed.
- Continuous compliance with 21CFR Part 11, cGMP, GMP and MHRA, EU Annex 11 etc
- Inventories realized are reduced drastically
- Quality of the final product realized is made an utmost priority.
- The process is fast, automated and very affordable.
- Data capture ensures accuracy, document preparation, and QA data review
- Makes it easier for Life Science companies to access and track batch records. It also helps them realize and change complex processes easily- Hence, speeding up the time it takes for the product to get to the market.
- Guarantees customer Satisfaction with Process Transparency and Regulatory Compliance results in running business.
- Facilitates organizing and controlling the individual template of processes and equipment operations.
AmpleLogic Batch Record Issuance Software complies with Electronic Record Standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH