Quantachrome Instruments announces the release of their 21 CFR Part 11 compliant NOVA BET Surface Area Analyzer system to meet the regulatory requirements for electronic records within the pharmaceutical industry as set forth by the US Food and Drug Administration (FDA). The FDA has mandated that 21 CFR Part 11 compliant systems be utilized in the pharmaceutical industry where electronic records are generated. The compliant version of the NOVA BET Surface Area Analyzer adopts new hardware and software design to allow for easy integration into the pharmaceutical laboratory. New compliant software (NOVAWin2) allows for secure operation of the instrument, data acquisition and report generation.

Amongst the new functionalities included are:

• Tamper resistant data files
• Required login with unique user name / password combination
• Fully detailed audit trail
• Accessibility level programmable by system administrator
• Programmable session time-out (auto logoff)
• Unique report identification; and a host of other features to ensure full compliance.