抄録
FDA issued a regulation in 1997 that outlines its criteria for acceptance of electronic records, electronic signatures, and handwritten signatures. The criteria were provided in response to industry requests. The regulation, 21 CFR Part11, allows electronic records to be considered equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by FDA and includes good laboratory practice (GLP), good clinical practice (GCP), and current good manufacturing practice (CGMP). The new regulations primarily require analytical laboratories to use validated equipment and computer systems; secure retention of electronic records to instantly reconstruct analyses; userindependent, computer-generated, time-stamped audit trails; system and data security, data integrity, and confidentiality through limited authorized system access; secure electronic signatures for closed and open systems; and digital signatures for open systems. 21 CFR Part11 is adapted when exporting the tablet and original medicine which are medical supplies to the U.S. Agilent Technologies supplies the analytical instrument and NDS (Network Data System) corresponding to electronic record and electronic signature.
