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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
The VPAT was originally designed as a tool for vendors to document product compliance to Section 508 and facilitate government market research on ICT with accessible features. Many people started to call the completed document a "VPAT" but the wider procurement community would prefer to call it a product Accessibility Conformance Report, or ACR.
A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. A technical standard includes definition of terms ...
BS 7373-1:2001 Guide to the preparation of specifications [4] BS 7373-2:2001 Product specifications. Guide to identifying criteria for a product specification and to declaring product conformity [5] BS 7373-3:2005, Product specifications. Guide to identifying criteria for specifying a service offering [6]
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation.
A risk management plan is a document to foresee risks, estimate impacts, and define responses to risks. It also contains a risk assessment matrix.According to the Project Management Institute, a risk management plan is a "component of the project, program, or portfolio management plan that describes how risk management activities will be structured and performed".
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The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...