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Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. [1] [2] All residues are removed to ...
Soft independent modelling by class analogy (SIMCA) is a statistical method for supervised classification of data. The method requires a training data set consisting of samples (or objects) with a set of attributes and their class membership. The term soft refers to the fact the classifier can identify samples as belonging to multiple classes ...
More generally, for a class of objects on which an equivalence relation is defined, a canonical form consists in the choice of a specific object in each class. For example: Jordan normal form is a canonical form for matrix similarity. The row echelon form is a canonical form, when one considers as equivalent a matrix and its left product by an ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Suppose some given data points each belong to one of two classes, and the goal is to decide which class a new data point will be in. In the case of support vector machines, a data point is viewed as a p {\displaystyle p} -dimensional vector (a list of p {\displaystyle p} numbers), and we want to know whether we can separate such points with a ...
A test plan is usually prepared by or with significant input from test engineers. [1] Depending on the product and the responsibility of the organization to which the test plan applies, a test plan may include a strategy for one or more of the following: Design verification or compliance test – to be performed during the development or ...
One-class classification. In machine learning, one-class classification ( OCC ), also known as unary classification or class-modelling, tries to identify objects of a specific class amongst all objects, by primarily learning from a training set containing only the objects of that class, [1] although there exist variants of one-class classifiers ...
person, office, or agency responsible for questions on the test method, updates, and deviations. significance or importance of the test method and its intended use. terminology and definitions to clarify the meanings of the test method. types of apparatus and measuring instrument (sometimes the specific device) required to conduct the test.