1Working Group on Information Technology. Good Laboratory Practice Guidelines for the Archiving of Electronic Raw Data in a GLP Environment [J]. Qual Assur J, 2003, 7:262- 269.
2OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring No. 10: GLP Consensus Document [Z]. The Application of the Principles of GLP to Computerised System. Environment Monograph No. 116 ; Environment Directorate, OECD. Paris, 1995.
3Electronic Reoords; Electronic Signatures [Z] . 21CFR Part 11 (Rule 11), US Food and Drug Administration, 20 March, 1997.
4Guidance for IndustryPart 11, Electronic Records; Elec tronic Signatures Scope and Application, Draft Guidance[Z]. February, 2003.
5Good Laboratory Practice for Nonclinical Laboratory Studies [Z] . USA 21 CFR part 58.
6Sandy Weinberg. Regulation of Computer Systems[M]. In "Sandy Weinberg edited Good Laboratory Practice Regulations fourth edition, informa Healthcare USA Inc,New York, 2007:111- 112.
7Electronic Records and electronic signatures Scope and Appli cation [M] . USA 21 CFR part 11-12.
8Alex D. Kanarek. International regulations govering GLP [M] . In Alex D. Kanarek edited Good Laboratory Prctice 3rd edition, D&.MD publication, New York, 2007: 17-18.
9Sandy Weinberg. Appling 21 CFR part 11 to the Laboratory Environment [M]. In Sandy Weinberg edited Good Labora- tory Practice third edition Revised and Eexpanded. Marcel Deker Inc. New York, 2003:132-133.
10Jurg P. Seiler. The archives [Z]. In Jurg P. Seiler edited Good Laboratory Practice--the Why and the How, Spring er, European Union, 2005: 278.
