New riboprinter software allows compliance with 21 cfr part 11 for electronic record security
The newly released software for the RiboPrinter® Microbial Characterisation System, available from Thermo Scientific Limited, allows compliance with the Code of Federal Regulations for electronic record security (21 CFR Part 11) - a major requirement of industries regulated by the U.S. Food and Drug Administration (FDA).
For pharmaceutical, biotechnical and other FDA-regulated industries, 21 CFR Part 11 compliance is essential for any system that stores data. The RiboPrinter® system stores all information about an analysed isolate, including the ribotype fingerprint, links to any information associated with that pattern, an accurate history of data changes, the source of the isolate, and any additional presumptive identification information obtained.
Source : Thermo Scientific. View archived contact details
Posted on April 14, 2004