Abstract: To improve the manufacturing efficiency of biologics, such as antibody drugs, a quality engineering framework was designed. Within this framework, critical steps and parameters in the manufacturing process were studied. Identification of these critical steps and critical parameters allows a deeper understanding of manufacturing capabilities, and suggests to process development department process control standards based on actual manufacturing capabilities as part of a PDCA (plan-do-check-act) cycle. This cycle can be applied to each manufacturing process so that it can be standardized, reducing the time needed to establish each new process.
Abstract: Prediction of fault-prone modules provides one way to
support software quality engineering. Clustering is used to determine
the intrinsic grouping in a set of unlabeled data. Among various
clustering techniques available in literature K-Means clustering
approach is most widely being used. This paper introduces K-Means
based Clustering approach for software finding the fault proneness of
the Object-Oriented systems. The contribution of this paper is that it
has used Metric values of JEdit open source software for generation
of the rules for the categorization of software modules in the
categories of Faulty and non faulty modules and thereafter
empirically validation is performed. The results are measured in
terms of accuracy of prediction, probability of Detection and
Probability of False Alarms.