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Life cycle management guidance document

In addition to the European GMP Guide, Pharmaceutical Inspections Convention Scheme (PIC/S) has an impact on pharmaceutical companies situated mainly in Europe. The Pharmaceutical Inspections Convention Scheme tries to harmonize inspections across the member countries. Therefore, even if the documents are not legally binding, they will be used by inspectors to measure companies against. This organization published in 2003 a new guidance document for the life-cycle management of computerized systems. [Pg.2]

Alarm philosophy encompasses basic definitions, key work practices, and various processes as well as the alarm system performance goals and details about the, roles, and responsibilities. This facility specific document provides guidance for a consistent approach to alarm management and defined activities of the alarm management life cycle. Major positive issues (see Fig. IX/4.4.2-1 and Table IX/4.4 1), addressed by alarm philosophy shall include but are not limited to the following ... [Pg.665]

See other pages where Life cycle management guidance document is mentioned: [Pg.247]    [Pg.31]    [Pg.32]    [Pg.93]    [Pg.661]    [Pg.344]    [Pg.528]    [Pg.13]    [Pg.120]   
See also in sourсe #XX -- [ Pg.25 ]



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