|
By definition, data and result files (DUX) that are created by the DU
800 UV/Vis Spectrophotometer are electronic records. Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures came into effect on 20 August 1997 and sets forth criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. People using electronic signatures must certify to the agency that the electronic signature in their system are intended to be the legally binding equivalent of traditional handwritten signatures.
|
For more information, please refer to:
Code of Federal Regulations
Title 21, Part 11 : Electronic Records; Electronic Signatures
U.S. Government Printing Office
http://www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1
(CITE: 21CFR11.1)
The booklet "21 CFR Part 11 Compliance with the DU 800 UV/Vis
Spectrophotometer" from Beckman Coulter shows how the DU 800 UV/Visible Spectrophotometer and its System and Applications Software, Version 2.0, or later, can help the customer to become compliant with the regulations promulgated in 21 CFR Part 11. The booklet is available for download below.
"DU 800 System Support of 21 CFR Part 11 Compliance"
gives you an overview in regard to the implementation of 21 CFR Part 11 features.
|
