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The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
The PIC/S guideline (PIC/S 2004) defines this as a 'computer related system'. [10] Much effort is expended within the industry upon validation activities, and several journals are dedicated to both the process and methodology around validation, and the science behind it. [11] [12] [13] [14]
The WHO Smart Guidelines are part of a broader global trend of digitizing clinical guidelines to make them more actionable in healthcare systems. For example, the Centers for Disease Control and Prevention (CDC) in the United States developed the "Adapting Clinical Guidelines for the Digital Age" (ACG) initiative, which promotes a holistic ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
A protocol implementation conformance statement (PICS) is a structured document which asserts which specific requirements are met by a given implementation of a protocol standard. [1] It is often completed as a record of formal protocol conformance test results, and some automated testing systems machine-author a PICS as output. [ 2 ]
The San Francisco 49ers on Monday suspended linebacker De'Vondre Campbell for the final three games of the regular season for refusing to play Thursday night against the Los Angeles Rams.. Niners ...
Good engineering practice (GEP) is engineering and technical activities that ensure that a company manufactures products of the required quality as expected (e.g., by the relevant regulatory authorities).
From December 2009 to December 2012, if you bought shares in companies when H. Ross Perot, Jr. joined the board, and sold them when he left, you would have a -24.7 percent return on your investment, compared to a 29.7 percent return from the S&P 500.