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).

The new Windows®-based software includes four levels of security that determine user access to certain features, along with audit trails that track and record changes to data.

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.

This software release also introduces the option for Remote Client Access, which allows users to analyse RiboPrinter® system data from their desktop or other computers outside the laboratory.

The RiboPrinter® Microbial Characterisation System is useful in many applications, including strain-level identification, pinpointing sources of contamination, clinical trial support, research and development, and ensuring culture integrity.

The RiboPrinter® system is available from Thermo Scientific Limited throughout Europe and Australia.

All other countries please contact DuPont Qualicon.