GxP and 21CFR Part 11 Compliance Support

GxP Support

Instruments used in regulated applications require additional controls and validation to satisfy GxP (GLP, GCP, GMP) regulations and 21CFR Part 11 compliance. Reichert has designed software and services to help customers operate in these regulated environments.

Reichert Advantages

  • Base software is GxP and 21CFR Part 11 compliant – no need to purchase additional “packages”
  • GxP services provide full qualification and validation support

Software Controls – including 21CRF Part 11 Compliance

The integrity of electronic records if paramount for compliance. Reichert has included the following features to support your applications:

  • Access controls to ensure data integrity
  • Configurable authorization levels for creating & running experiments, options, and data export
  • Logs and audit trails to track modifications and maintain a complete history
  • Data export in Excel and text formats to link with user documentation and archiving

GxP Services

Reichert’s GxP service package ensures the system performs to standard and is maintained in a validated state. The services include the following:

  • Instrument Qualification – IQ/OQ/PQ – includes thorough on-site testing and complete documentation package required to qualify the instrument for meeting all requirements
  • Re-qualification (RQ) – Annual re-qualification to maintain the system in a validated state and support the ongoing qualification process throughout the lifetime of the instrument
  • 21CFR Compliance assessment and process recommendations