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Aesthetics Medicine
Published in P. Arpaia, U. Cesaro, N. Moccaldi, I. Sannino, Non-Invasive Monitoring of Transdermal Drug Delivery, 2022
P. Arpaia, U. Cesaro, N. Moccaldi, I. Sannino
The reproducibility of an experiment refers to a set of measurement conditions that includes different locations, operators, measuring systems, and replicate measurements on the same or similar objects. Technically, the reproducibility is the capability of an experiment to obtain consistent measures when the procedure is carried out in a different context (homologues devices, different laboratory, or operator). It can be considered as a characteristic of an experiment, meaning its aptitude to provide slightly dispersed measures in different conditions [152].
Validation of Sterilizing-Grade Filters
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
There are two main reasons to validate processes. The first is obvious, whereas the second is often known but rarely quantified. Good manufacturing practice (regulatory requirements)—Various worldwide regulatory bodies require validation of manufacturing processes for LVPs and SVPs, ophthalmics, veterinary medicines, bulk chemicals, and in vitro diagnostics.Good business practice—It is essential to understand that an out-of-control process increases the amount of rework or scrap incurred, thereby increasing cost. A controlled process gives reproducibility and product consistency within known limits. A controlled process also aids regulatory compliance and, therefore, provides a license to do business. The ultimate aim in both cases is patient safety.
PLM Components
Published in Uthayan Elangovan, Product Lifecycle Management (PLM), 2020
Manufacturing process in addition to product high quality are connected to each other; they rely on reproducibility to achieve the preferred goals. Enterprise simplify the product growth process by implementing a PLM system. For any manufacturer, maintaining the quality of a product is the primary emphasis. To make certain continued success, the system needs to be supported by quality procedures created to identify, correct and maintain standards. Quality management (QM) systems allows compliance with the most stringent top-quality standards, including the automotive sector (TS), medical devices (FDA, 21 CFR Part 11), ISO requirements, and correspondingly reduced cost of quality. QM is a reliable system for managing high quality equates an enterprise’s purpose on top of goals right into plans and also resources which aid every participant of the enterprise to embrace standard operating procedures.
Laboratory load-based testing and performance rating of residential heat pumps in heating mode
Published in Science and Technology for the Built Environment, 2023
Parveen Dhillon, Li Cheng, W. Travis Horton, James E. Braun
There is also ongoing research to evaluate the repeatability, reproducibility, and representativeness of load-based testing that is extremely important in assessing its potential for use in future standards. Repeatability refers to the consistency in a test unit’s measured performance when the test procedure is applied multiple times in the same lab, whereas reproducibility refers to the consistency in a test unit’s measured performance across different test facilities. Assessing repeatability and reproducibility involves the application of round-robin tests across different laboratories for multiple heat pumps. Representativeness involves understanding how well the virtual building model mimics building behavior and its interaction with the equipment. Evaluating representativeness requires field testing for different building types and using that data to validate emulated behavior in the laboratory for the same equipment. Finally, there is a need to perform comprehensive comparisons of seasonal performance ratings determined using load-based and steady-state testing approaches to better understand the advantages and disadvantages of each. Data obtained in repeatability, reproducibility, and representativeness studies could be employed for this purpose.
Repeatability, reproducibility, and agreement of three computational methods to approximate the functional flexion-extension axis of the tibiofemoral joint using 3D bone models of the femur
Published in Computer Methods in Biomechanics and Biomedical Engineering, 2019
Rocio Lozano, Stephen M. Howell, Maury L. Hull
To assess the efficacy of any method used to approximate the functional FE axis, two important metrics are repeatibility and reproducibility (National Institute of Standards and Technology 2007; Bartlett and Frost 2008). Since confusion exists surrounding the meaning and hence use of the terms in the literature, definitions of these metrics are appropriate. Repeatability refers to the variation in repeat measurements made on the same subject under identical conditions (National Institute of Standards and Technology 2007). Identical conditions require that measurements are made by the same instrument or method, the same observer (or rater) if human input is required, and over a short period of time during which the value of the dependent variable of interest is constant. Variability in measurements made on the same subject in a repeatability study can be ascribed only to errors due to the measurement process itself (Bartlett and Frost 2008). Reproducibility refers to the variation in measurements made on a subject under changing conditions (National Institute of Standards and Technology 2007). The changing conditions may be due to different measurement methods or instruments being used, different observers (or raters), or over a period of time during which the ‘error free’ value of the dependent variable of interest could undergo non-negligible change (Bartlett and Frost 2008). Although previous methods based on fitting circles, cylinders, and spheres have been used to approximate the functional FE axis, few studies have quantified the repeatability and reproducibity of the methods used. Moreover, the methods were not described with sufficient detail to enable their reproduction.