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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.
ODF 1.2 defines precisely the conformance needs. The specification defines conformance for documents, consumers, and producers, with two conformance classes called conforming and extended conforming. It further defines conforming text, spreadsheet, drawing, presentation, chart, image, formula and database front end documents.
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
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 ...
Full-text documents of scientific and technical information dating primarily from 1991 to the present day are available for download. Legacy documents are added as they become available in electronic format. Most DOE technical reports from the 1940s to 1991 are still only available in hard copy.
A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and ...
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 ...
Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, [1] and version 3.0 was finalized on October 8 of the same year. [2] As of August 2016, the most current version is 3.2.2, released on July 16, 2008. [3] A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4]