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Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions.
The United Nations Framework Convention on Climate Change (UNFCCC or FCCC) is an international environmental treaty negotiated at the United Nations Conference on Environment and Development (UNCED), informally known as the Earth Summit, held in Rio de Janeiro from 3 to 14 June 1992.
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Annex 19 – Safety Management (Since 14 November 2013) Annex 5, Units of Measurement to be Used in Air and Ground Operations , named in its Table 3-3 three "non- SI alternative units permitted for temporary use with the SI": the foot (for vertical distance = altitude ), the knot (for speed ), and the nautical mile (for long distance).
isbn 0-11-985366-3 Markus Hartmann and Florence Hartmann-Vareilles, The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research? , PLoS Clin Trials. 2006 June; 1(2): e13 External links
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Standards And Recommended Practices (SARPs) are technical specifications adopted by the Council of ICAO in accordance with Article 37 of the Convention on International Civil Aviation in order to achieve "the highest practicable degree of uniformity in regulations, standards, procedures and organization in relation to aircraft, personnel, airways and auxiliary services in all matters in which ...