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 specification (technical standard), 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 reality, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, A Guide to the Project Management Body of Knowledge, 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 assu ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Requirement
In engineering, a requirement is a condition that must be satisfied for the output of a work effort to be acceptable. It is an explicit, objective, clear and often quantitative description of a condition to be satisfied by a material, design, product, or service. A specification or spec is a set of requirements that is typically used by developers in the design stage of new product development, product development and by testers in their verification process. With iterative and incremental development such as agile software development, requirements are developed in parallel with design and implementation. With the waterfall model, requirements are completed before design or implementation start. Requirements are used in many engineering fields including engineering design, system engineering, software engineering, enterprise engineering, New product development, product development, and process optimization. Requirement is a relatively broad concept that can describe any nec ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Metal Fatigue
In materials science, fatigue is the initiation and propagation of cracks in a material due to cyclic loading. Once a fatigue crack has initiated, it grows a small amount with each loading cycle, typically producing striation (fatigue), striations on some parts of the fracture surface. The crack will continue to grow until it reaches a critical size, which occurs when the stress intensity factor of the crack exceeds the fracture toughness of the material, producing rapid propagation and typically complete fracture of the structure. Fatigue has traditionally been associated with the failure of metal components which led to the term metal fatigue. In the nineteenth century, the sudden failing of metal railway axles was thought to be caused by the metal crystallising because of the brittle appearance of the fracture surface, but this has since been disproved. Most materials, such as composites, plastics and ceramics, seem to experience some sort of fatigue-related failure. To aid ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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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 constan ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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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 specification (technical standard), specifications and that it fulf ... References Analytical chemistry {{Analytical-chem-stub ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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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). However, 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 ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Elsevier
Elsevier ( ) is a Dutch academic publishing company specializing in scientific, technical, and medical content. Its products include journals such as ''The Lancet'', ''Cell (journal), Cell'', the ScienceDirect collection of electronic journals, ''Trends (journals), Trends'', the ''Current Opinion (Elsevier), 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 include digital tools for Data management platform, 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 2022 Elsevier published more than 600,000 articles annually in over 2,800 journals. As of 2018, its archives contained over 17 million documents and 40,000 Ebook, e-books, with over one b ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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ISO/IEC 27001
ISO/IEC 27001 is an information security standard. It specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system (ISMS). Organizations with an ISMS that meet the standard's requirements can choose to have it certified by an accredited certification body following successful completion of an audit. There are also numerous recognized national variants of the standard. It was originally published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 2005, with revisions in 2013 and 2022. Rationale Most organizations have a number of information security controls. However, without an information security management system (ISMS), controls tend to be somewhat disorganized and disjointed, having been implemented often as point solutions to specific situations or simply as a matter of convention. Security controls in operation typ ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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ISO/IEC 15408
ISO/IEC JTC 1, entitled "Information technology", is a joint technical committee (JTC) of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Its purpose is to develop, maintain and promote standards in the fields of information and communications technology (ICT). JTC 1 has been responsible for many critical IT standards, ranging from the Joint Photographic Experts Group (JPEG) image formats and Moving Picture Experts Group (MPEG) audio and video formats to the C and C++ programming languages. History ISO/IEC JTC 1 was formed in 1987 as a merger between ISO/TC 97 (Information Technology) and IEC/TC 83, with IEC/SC 47B joining later. The intent was to bring together, in a single committee, the IT standardization activities of the two parent organizations in order to avoid duplicative or possibly incompatible standards. At the time of its formation, the mandate of JTC 1 was to develop base standards in information t ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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International Organization For Standardization
The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and () it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by the International Electrotechnical Commission.Editors of Encyclopedia Britannica. 3 June 2021.Inte ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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GUID Partition Table
The GUID Partition Table (GPT) is a standard for the layout of partition tables of a physical computer storage device, such as a hard disk drive or solid-state drive. It is part of the Unified Extensible Firmware Interface (UEFI) standard. It has several advantages over master boot record (MBR) partition tables, such as support for more than four primary partitions and 64-bit rather than 32-bit logical block addressing, logical block addresses (LBA) for blocks on a storage device. The larger LBA size supports larger disks. Some BIOSes support GPT partition tables as well as MBR partition tables, in order to support larger disks than MBR partition tables can support. GPT uses universally unique identifiers (UUIDs), which are also known as globally unique identifiers (GUIDs), to identify partitions and partition types. All modern personal computer operating systems support GPT. Some, including macOS and Microsoft Windows on the x86 architecture, support booting from GPT partitio ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |