Quantachrome Instruments offers 21 CFR Part 11 compliant NOVA BET Surface Area Analyzers 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 hardware and software design to allow for easy integration into the pharmaceutical laboratory. The compliant software allows for secure operation of the instrument, data acquisition and report generation. Amongst the functionalities included are:
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![]() Figure 1: Selecting security level in NovaWin-CFR |
![]() Figure 2: Setting user properties for new users. |
![]() Figure 3: Example of system log window |