FDA Software

Logging software in accordance with FDA guidelines

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Celsius 2007 Screenshot: Managing user permissions
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Celsius 2007 Screenshot: Note on permissions
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Celsius 2007 Screenshot: Electronic signatures

For all models of the P class, the FDA version of the "Celsius software" is available at extra charge. The manufacturers of FDA-regulated products are under obligation to continuously document all process parameters and to archive them in the long-term. The Memmert FDA software fulfils, within a closed system, the following regulations and requirements of electronic generation and storage of production and quality assurance documents (Electronic Records):

  • User administration in User Groups, by the administrator
  • The users and administrators of electronic records are authentic and uniquely identifiable
  • User-related access protection for individual system functions
  • Storage of profile and logging files in a file format that cannot be manipulated
  • All modifications are permanently documented throughout the course of the archiving period
  • Monitoring of logging in and logging out processes, changes to raw data are documented with the help of an audit trail (timestamp, signature and type of change to electronic records) and are protected against manipulation
  • The electronic signature, inseparably connected to the electronic record, uniquely identifies the author responsible
  • Complete integration into the Windows NT, Windows 2000 or XP Professional security system (administration of rights, user and password administration)
  • Option of audit trail data export to generally readable HTML format
  • Access option to data for the inspectors of regulatory authorities
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Celsius FDA Screenshot: Lock Celsius FDA
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Celsius FDA Screenshot: Audit-Trail
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Celsius FDA Screenshot: Audit-Protocol