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6FDA.Guidance for Industry 21 CFR Part 11 ;Electronic Records; Electronic Signatures Validation[OL],2001-08[2012-10]. www. fda.gov/downloads/Regulatorylnformation/Guidances/ UCM 124946.pdf.
7Huber L, Winter W.lmplementing 21 CFR Part 11 in Analytical Laboratories: Part 6, Biometric Identification: Limits and Possibilities [OL]. 2000-1112012-10]. cp.chem.agilent.com/ Library/articlereprints/Public/59880947.pdf.
8Huber L, Winter W. Implementing 21 CFR Part 11 in Analytical Laboratories: Part 4, Data Migration and Long-Term Archiving for Ready Retrieval[J]. BioPharm ,2000,13(6):58-64.
9Winter W, Huber L. Implementing 21 CFR Part 11 in Analytical Laboratories: Part 2,Security Aspects for Systems and Applications [J]. BioPharm, 2000, 13(1):44-50.
