Centrifuges that Support 21 CFR Part 11 Compliance

As technology and software advance, security and protection of data is becoming increasingly important to ensure a properly functioning lab environment. Floor-standing centrifuges are vital to many bioproduction processes and must support regulations when used in Good Manufacturing Practice (GMP) environments. Innovative features built into Optima XPN ultracentrifuge and Avanti JXN high performance centrifuge support compliance while eliminating much of the administrative work of other systems. 

User Management

  • Multi-level, unique, user logins and passwords, links individuals to the instrument and procedures entered 
  • Instrument requires username and PIN authentication to operate 
  • Generates record of operation and captures electronic signatures
  • User specific pre-defined programs limit potential for errors

Data Logging Parameters for Traceability

  • Records data usage by user, providing an audit trail of centrifuge activities
  • Provides read-only records of centrifuge activities within the instrument
  • Reports available as a PDF, XML, or CSV file and exports to a USB device if needed

Download the Centrifuge Support 21 CFR Part 11 Compliance Brochure to discover additional ways these instruments support GMP requirements. 

Download Brochure

 

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