EBMR Software - Electronic Batch Manufacturing Records

EBMR Software - Electronic Batch Manufacturing Records

About EBMR Software eBMR for Pharma is very critical for Pharma Manufacturing for various reasons. Even today, surprisingly, lot of big pharmaceutical manufacturing companies have been capturing the batch manufacturing details on paper. This paper based BMR involves lot of effort in printing all the process parametric data from different process steps of the batch manufacturing. Human beings have to walk across the manufacturing floor, collect these paper printouts, compile them and sometimes, they may have to repeat this process and manually got to verify the same by respective QA individuals.

Where should one start the eBMR journey?

This process parametric data comes from wide variety of PLCs monitoring the processes. When I say, wide variety of PLCs, this means from different vendors, different models that got evolved a long period of 20-30 years. How do we bring all the data that is coming from these machines into an eBMR? What to do with existing investments that the manufacturers have made for the automation of the L1 and L2 layers of automation, where there is lot of HMI/SCADA. Lot of this machinery comes with the embedded PLCs and how do we ensure that these machines are 21 CFR Part 11 compliant? Now, the manufacturers’ have the dilemma, should they make each and every machine 21 CFR Part 11 compliant first or should they go for an eBMR solution? Is eBMR solution going to solve all the problems in one shot? There is also a concern from some of the manufacturers that eBMR solution is expensive and difficult to scale because of cost reasons and validations involved. What is the truth here? Upgrading of all the machinery on the floor for 21 CFR Part 11 compliance is not an option obviously, we all know that the new machinery comes with the 21 CFR Part 11 compliance but how to deal with the older machinery? Should the manufacturer invest into the HMI/SCADA automation? This is something, an option in the past but with the availability of proven new IIOT technologies, it does not make sense to invest into the HMI/SCADA now just for the eBMR purposes. HMI/SCADA has its own justification.

What about the Data retention?

Unlike, other eBMR vendors, at Atachi we take the responsibility of data retention throughout the life of the product. During this whole life of the product (i.e., tablets, vaccines, etc.) the manufacturer does not have to worry about upgrading their eBMR platform and the associated reporting tools, data warehouses databases, etc. This is a big task and obviously expensive and tedious life software and hardware cycle management task. Atachi NGIMES provides the eBMR for any batch throughout the data retention period and beyond for continuous improvement and manufacturing insights.

What functionalities do you need as part of eBMR? Today, lot of pharma manufacturers, especially Indian Pharma manufacturers capture lot of information in their BMR on paper. When they try to digitize this paper bmr into eBMR software using the international eBMR platforms, this functionalities that they are capturing on paper is not available for one single cost or license. What does it mean? When you generate a BMR, the BMR template needs to be created at first and that needs to be reviewed and approved by QA department. This functionality is sold as a separate package by some MES vendors. As part of the preparation of the raw materials prior to production, warehouse performs weighing and dispensing.

This functionality is offered as a standalone package by lot of MES vendors and small Indian software firms. When the pharma manufacturer starts deploying the functionality one by one, the integration of these functionalities becomes challenge. Some MES platforms have integration issues with the machinery on the production floors hence demanding the situation of retrofitting these machineries or upgrading the machineries with 3rd party OPC software or IIOT gateways.

This is becoming a challenge for the Pharma manufacturers in digitizing their paper based BMR.