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Electronic record keeping

Some fairly common mistakes made in managing electronic SOPs, protocols, and changes to them are listed below. If these can be avoided, the resulting computer system should meet the requirements of the US, Organization for Economic Cooperation and Development (OECD), and Ministry of Health, Labor, and Welfare (MHLW) GLP standards as well as the FDA s Rule on Electronic Record Keeping Electronic Signatures. ... [Pg.1030]

In a GLP-compliant electronic record keeping system, original raw electronic data will not be altered, but these data can be presented and interpreted for reporting. Any changes to the raw data are documented and maintained as audit trails. The audit trail becomes a part of the raw data for the study and is archived as such. [Pg.1039]

See other pages where Electronic record keeping is mentioned: [Pg.165]    [Pg.1027]    [Pg.1029]    [Pg.1030]    [Pg.1031]    [Pg.1033]    [Pg.1035]    [Pg.1035]    [Pg.1035]    [Pg.1036]    [Pg.1037]    [Pg.1039]    [Pg.1041]    [Pg.1043]    [Pg.1045]    [Pg.1047]    [Pg.1049]    [Pg.1051]    [Pg.1053]    [Pg.1055]    [Pg.1057]    [Pg.1059]    [Pg.1061]    [Pg.1063]    [Pg.1065]    [Pg.1067]    [Pg.1069]    [Pg.1071]    [Pg.1071]    [Pg.1073]    [Pg.1075]    [Pg.1077]    [Pg.1079]    [Pg.1081]    [Pg.1083]    [Pg.1085]   
See also in sourсe #XX -- [ Pg.1043 , Pg.1061 , Pg.1066 , Pg.1070 , Pg.1074 , Pg.1077 , Pg.1081 ]



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