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Installation Qualification
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 ide ... [...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] |
