Electronic Batch Recording Solutions pdf free download
During the last years the technology around Electronic Batch Recording Systems (EBRS) has made huge progress. Despite many examples of successful EBRS implementations traditional paper batch tickets remain com-mon practice in the pharmaceutical industry. The benefits of EBRS deployment to operations and supply chain are in conflict with significant change management efforts and investments required for system deployment.
During the last years the technology around Electronic Batch Recording Systems (EBRS) has made huge progress. Despite many examples of successful EBRS implementations traditional paper batch tickets remain com-mon practice in the pharmaceutical industry. The benefits of EBRS deployment to operations and supply chain are in conflict with significant change management efforts and investments required for system deployment.
This means that a careful and
systematic evaluation is recommended to justify the implementation.
Unfortunately, existing evaluation examples were found to be incomplete since
they primarily rely on using investment costs, neglect intangible performance measures
and do not consider the impact from structural, process technological and
organizational differences of the company which determine the change management
efforts required for EBRS deployment.
In order to overcome this gap
this work introduces a newly developed hierarchical evaluation model that
allows a holistic assessment of the required input aspects, the output benefits
as well as the overall performance value through EBRS deployment while taking
individual preferences of the decision-makers into account.
Various quantitative and
qualitative studies have been conducted through-out the pharmaceutical industry
to develop the model. A real-life pharmaceutical company has been selected to
apply the model and verify its effectiveness.
The case study determined that
the implementation of electronic batch re-cording systems does not provide an
optimization per se. The improvements in the area of compliance, process time,
flexibility, costs and information exchange are to be assessed against the
change management and investments required.
The model efficiently supports
decision-makers in the evaluation of different technical EBRS implementation
designs and different organizational settings. The model and the underlying
evaluation software are flexibly designed so that it can be easily applied to
other cases and modified, if necessary.
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