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. 
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.










No comments:

Post a Comment