Quantachrome Instruments offers 21 CFR Part 11 compliant software for their BET surface area analyzer instruments 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 instruments and software utilize complimentary hardware and software design to allow for easy integration into the pharmaceutical laboratory. The compliant Windows®-based 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.