EBMR Software - Electronic Batch Manufacturing Records

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EBMR Software - Electronic Batch Manufacturing
Records
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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.
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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.
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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.
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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.
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