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Monitoring, Reporting And Verification
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V". In practice, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: * "Validation. The assurance that a product, service, or system meets the needs of the customer and other ident ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Requirement
In product development and process optimization, a requirement is a singular documented physical or functional need that a particular design, product or process aims to satisfy. It is commonly used in a formal sense in engineering design, including for example in systems engineering, software engineering, or enterprise engineering. It is a broad concept that could speak to any necessary (or sometimes desired) function, attribute, capability, characteristic, or quality of a system for it to have value and utility to a customer, organization, internal user, or other stakeholder. Requirements can come with different levels of specificity; for example, a requirement specification or requirement "spec" (often imprecisely referred to as "the" spec/specs, but there are actually different sorts of specifications) refers to an explicit, highly objective/clear (and often quantitative) requirement (or sometimes, ''set'' of requirements) to be satisfied by a material, design, product, or serv ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Pharmacopoeia
The ''European Pharmacopoeia'' (''Pharmacopoeia Europaea'', ''Ph. Eur.'') is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use. Legal basis The ''European Pharmacopoeia'' has a legally binding character. It is used as an official reference to serve public health, and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product. The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) sig ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Monograph
A monograph is a specialist work of writing (in contrast to reference works) or exhibition on a single subject or an aspect of a subject, often by a single author or artist, and usually on a scholarly subject. In library cataloging, ''monograph'' has a broader meaning—that of a nonserial publication complete in one volume (book) or a definite number of volumes. Thus it differs from a serial or periodical publication such as a magazine, academic journal, or newspaper. In this context only, books such as novels are considered monographs.__FORCETOC__ Academia The English term "monograph" is derived from modern Latin "monographia", which has its root in Greek. In the English word, "mono-" means "single" and "-graph" means "something written". Unlike a textbook, which surveys the state of knowledge in a field, the main purpose of a monograph is to present primary research and original scholarship ascertaining reliable credibility to the required recipient. This research is prese ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Laboratory Practice
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests. GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of products in development (including pharmaceuticals) for people, animals, and the environment. GLP, a data and opera ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Depreciation
In accountancy, depreciation is a term that refers to two aspects of the same concept: first, the actual decrease of fair value of an asset, such as the decrease in value of factory equipment each year as it is used and wear, and second, the allocation in accounting statements of the original cost of the assets to periods in which the assets are used (depreciation with the matching principle). Depreciation is thus the decrease in the value of assets and the method used to reallocate, or "write down" the cost of a tangible asset (such as equipment) over its useful life span. Businesses depreciate long-term assets for both accounting and tax purposes. The decrease in value of the asset affects the balance sheet of a business or entity, and the method of depreciating the asset, accounting-wise, affects the net income, and thus the income statement that they report. Generally, the cost is allocated as depreciation expense among the periods in which the asset is expected to be used. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Population
Population typically refers to the number of people in a single area, whether it be a city or town, region, country, continent, or the world. Governments typically quantify the size of the resident population within their jurisdiction using a census, a process of collecting, analysing, compiling, and publishing data regarding a population. Perspectives of various disciplines Social sciences In sociology and population geography, population refers to a group of human beings with some predefined criterion in common, such as location, race, ethnicity, nationality, or religion. Demography is a social science which entails the statistical study of populations. Ecology In ecology, a population is a group of organisms of the same species who inhabit the same particular geographical area and are capable of interbreeding. The area of a sexual population is the area where inter-breeding is possible between any pair within the area and more probable than cross-breeding with in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Analytical Balance
An analytical balance (or chemical ''balance'') is a class of balance designed to measure small mass in the sub-milligram range. The measuring pan of an analytical balance (0.1 mg resolution or better) is inside a transparent enclosure with doors so that dust does not collect and so any air currents in the room do not affect the balance's operation. This enclosure is often called a draft shield. The use of a mechanically vented balance safety enclosure, which has uniquely designed acrylic airfoils, allows a smooth turbulence-free airflow that prevents balance fluctuation and the measure of mass down to 1 μg without fluctuations or loss of product. Also, the sample must be at room temperature to prevent natural convection from forming air currents inside the enclosure from causing an error in reading. Single pan mechanical substitution balance is a method of maintaining consistent response throughout the useful capacity of the balance. This is achieved by maintaining a constant ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cross-validation (analytical Chemistry)
In analytical chemistry, cross-validation is an approach by which the sets of scientific data generated using two or more methods are critically assessed. The cross-validation can be categorized as either method validation or analytical data validation. See also * Validation (drug manufacture) * Verification and validation Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are ... References {{DEFAULTSORT:Cross-Validation (Analytical Chemistry) Analytical chemistry ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Elsevier
Elsevier () is a Dutch academic publishing company specializing in scientific, technical, and medical content. Its products include journals such as ''The Lancet'', ''Cell'', the ScienceDirect collection of electronic journals, '' Trends'', the '' Current Opinion'' series, the online citation database Scopus, the SciVal tool for measuring research performance, the ClinicalKey search engine for clinicians, and the ClinicalPath evidence-based cancer care service. Elsevier's products and services also include digital tools for data management, instruction, research analytics and assessment. Elsevier is part of the RELX Group (known until 2015 as Reed Elsevier), a publicly traded company. According to RELX reports, in 2021 Elsevier published more than 600,000 articles annually in over 2,700 journals; as of 2018 its archives contained over 17 million documents and 40,000 e-books, with over one billion annual downloads. Researchers have criticized Elsevier for its high profit marg ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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