相关论文: Risk management for analytical methods: conciliati…

The ultimate goal in the pharmaceutical sector is product quality. However this quality can be altered by the use of a number of heterogeneous information systems with different business structures and concepts along the lifecycle of the…

Regulatory affairs, which sits at the intersection of medicine and law, can benefit significantly from AI-enabled automation. Classification task is the initial step in which manufacturers position their products to regulatory authorities,…

Short product lifecycles and a high variety of products force industrial manufacturing processes to change frequently. Due to the manual approach of many quality analysis techniques, they can significantly slow down adaption processes of…

The use of machine learning systems in clinical routine is still hampered by the necessity of a medical device certification and/or by difficulty to implement these systems in a clinic's quality management system. In this context, the key…

Medical Artificial Intelligence (AI) involves the application of machine learning algorithms to biomedical datasets in order to improve medical practices. Products incorporating medical AI require certification before deployment in most…

Although AI systems are increasingly being leveraged to provide value to organizations, individuals, and society, significant attendant risks have been identified and have manifested. These risks have led to proposed regulations,…

Statistics experiences a storm around the perceived misuse and possible abuse of its methods in the context of the so-called reproducibility crisis. The methods and styles of quantification practiced in mathematical modelling rarely make it…

Context:Software Development Analytics is a research area concerned with providing insights to improve product deliveries and processes. Many types of studies, data sources and mining methods have been used for that purpose. Objective:This…

Systems that answer questions by reviewing the scientific literature are becoming increasingly feasible. To draw reliable conclusions, these systems should take into account the quality of available evidence from different studies, placing…

Although essential to revealing biased performance, well intentioned attempts at algorithmic auditing can have effects that may harm the very populations these measures are meant to protect. This concern is even more salient while auditing…

Software product quality can be defined as the features and characteristics of the product that meet the user needs. The quality of any software can be achieved by following a well defined software process. These software process results…

The study of associations and their causal explanations is a central research activity whose methodology varies tremendously across fields. Even within specialized subfields, comparisons across textbooks and journals reveals that the basics…

The collection, transfer and integration of research information into different research Information systems can result in different data errors that can have a variety of negative effects on data quality. In order to detect errors at an…

Artificial Intelligence (AI) and Machine-Learning (ML) models have been increasingly used in medical products, such as medical device software. General considerations on the statistical aspects for the evaluation of AI/ML-enabled medical…

Interim analyses for group-sequential decision making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to…

The control of manufacturing processes must satisfy high quality and efficiency requirements while meeting safety requirements. A broad spectrum of monitoring and control strategies, such as model- and optimization-based controllers, are…

When developing a safety-critical system it is essential to obtain an assessment of different design alternatives. In particular, an early safety assessment of the architectural design of a system is desirable. In spite of the plethora of…

At this time, quality is a strategic instrument of the entities' global management, but it is also a determining element of their competitive spirit. The importance given to quality is abundantly found in the preoccupations of the European…

Auditing of AI systems is a promising way to understand and manage ethical problems and societal risks associated with contemporary AI systems, as well as some anticipated future risks. Efforts to develop standards for auditing Artificial…

This document describes the statistical methods used in Itzhaky et al ("Systematic Review and Meta-analysis: Twenty-six Years of Randomized Clinical Trials of Psychosocial Interventions to Reduce Suicide Risk in Adolescents"). That paper is…