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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.
Conformance testing is applied in various industries where a product or service must meet specific quality and/or regulatory standards. This includes areas such as: [1] [3] [4] [7] [8] biocompatibility proofing; data and communications protocol engineering; document engineering; electronic and electrical engineering; medical procedure proofing
Often the data are contained in 'records' of various forms, such as on paper, microfilms or digital media. Hence technical data management is also concerned with record management involving technical data. Technical document management systems are used within large organisations with large scale projects involving engineering. For example, a ...
A certificate of conformance is defined in American commerce Archived 18 April 2010 at the Wayback Machine as a document certified by a competent authority that the supplied good or service meets the required specifications. A certificate of conformance is a lot/datecode specific certification that provides traceability of the goods back to the ...
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.
[1] The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time called the Isotretinoin Products Manufacturing Group (IPMG) under the direction of the Food and Drug Administration. The program launched on March 1, 2006, at the beginning of the annual meeting of the American Academy of Dermatology.
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 ...