Before implementing BIMS (Batch Record Issuance Management Software) developed by AmpleLogic, at Annora Pharma, we followed manual batch record issuance process.
The manual process involved the use of paper-based documents and signatures, which made it time consuming and challenging to track quality-related activities effectively, ensure compliance with regulatory requirements, assigning Batch Manufacturing Record (BMR) numbers to each batch of products, manually printing each document and stamping & signing each page was a tedious task and prone to making errors.
The need for BIMS software:
At Annora Pharma, we are commited to consistently provide Pharmaceutical Products with highest quality, safety and efficacy that meets the customer, applicable statutory and regulatory requirements.
As you are aware that manual processes are always time consuming and there are high chances of error. Hence, we recognized the need for an automated and streamlined batch record issuance system. The company sought a software solution that could automate its batch record issuance process, provide real-time visibility into batch-related activities, and ensure data integrity and compliance with regulatory requirements.
Annora Pharma is a part of Hetero group and they have been successfully using BIMS software from quite a while now, so it was a legacy that we carried forward at Annora Pharma, by implementing AmpleLogic’s BIMS software.
We found the software very effective and user friendly, as it is a web-based application that provides end-to-end batch record issuance management capabilities, including document management, deviation management, change control, training management, and audit management. The software is highly configurable and can be customized to meet our specific needs of Annora Pharma.
Implementation and results:
After implementing BIMS software, we experienced significant improvements in our overall batch record issuance process. The software provided real-time visibility into batch-related activities, enabling the company to identify and address issues promptly. The software
automated the workflow so there was reduced need to take any printouts for circulation, as key stakeholders can simply login and review, leading to faster communication and turnaround time of process execution.
The manual intervention has reduced considerably at every step, resulting in significant time savings. The software’s robust reporting capabilities provided valuable insights into batch-related metrics, enabling our company to make data-driven decisions to improve its batch record issuance process continually.
We highly recommend AmpleLogic software, as it has got excellent technical support and its key features has helped Annora Pharma with automatic batch issuance with an audit trail of documents, Control overprinting to avoid printing mistakes and ensure data integrity, Electronic signatures for better control and compliance, Management of document numbering & versioning to ensure that the correct version is used for each batch, multiple types of reports that can be generated for review.
Overall, the implementation of BIMS software has helped Annora Pharma to achieve its goal of a more streamlined and automated batch record issuance process. The company has seen significant improvements in operational efficiency, compliance, and customer satisfaction, and continues to rely on BIMS software as a vital tool in its batch record issuance process. We are confident to face any audit, as the software has ensured we are error free and fully compliant with 21 CFR PART 11.
Quote By Avanish
‘After implementing BIMS software, we experienced significant improvements in our overall batch record issuance process. The software provided real-time visibility into batch-related activities, enabling the company to identify and address issues promptly. The software automated the workflow so there was reduced need to take any printouts for circulation, as key stakeholders can simply login and review, leading to faster communication and turnaround time of process execution.’