21 CFR Part 11 Compliant
Surface Area & Pore Size Analyzer
for the Pharmaceutical Industry
Option Available in All NOVA e-Series Models
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.
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.
