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Nova Sofware- CFR 21 Part 11 Compliance

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

 

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:
  • 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.
Selecting security level in NovaWin-CFR
Figure 1: Selecting security level in NovaWin-CFR
Setting user properties for new users.
Figure 2: Setting user properties for new users.
Example of system log window
Figure 3: Example of system log window