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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.
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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".
Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
A CoC is a producer's declaration that equipment, e.g. a car or motorcycles comply with the given approved type. This document contains information about the equipment and its producer's identification, type approval number, other technical specifications. The content of a CoC is defined by the European regulation (Amendment IX, Regulation 92/53).
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 ...