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Live Webinar: Achieve 21 CFR Part 11 Compliance with STARe Thermal Analysis Software

Learn How STARe Software Supports FDA Compliance

Tổng quan chương trình

  • Scope and requirements of 21 CFR Part 11
  • Solutions offered by the METTLER TOLEDO STARe thermal analysis software
  • Access control and account management
  • Electronic records and audit trails
  • LIMS connectivity
  • Live Q&A with our experts

Regulation 21 CFR Part 11 provides detailed guidelines on how to create and manage electronic records and signatures. Compliance is obligatory for all FDA-regulated industries.

Key Objectives of 21 CFR Part 11

  • Generate electronic records and electronic signatures that are trustworthy, reliable, and equivalent to paper records
  • Detect and track any alterations to the electronic records

In This Webinar

We explore the scope and requirements of 21 CFR Part 11. We then explain the solutions offered by our STARe software for your thermal analysis system, covering all techniques such as differential scanning calorimetry (DSC), thermogravimetric analysis (TGA),  thermomechanical analysis (TMA), and dynamic mechanical analysis (DMA). We highlight the features of the 21 CFR Part 11 STARe software option that enable users to work within a compliant system.

Register now to join the live webinar and get the chance to ask our experts your questions!

21 CFR Part 11: The STARe Software Solution

STARe thermal analysis software is designed as a closed system. This means access is controlled by persons who are responsible for the content of the electronic records within that system.

The 21 CFR Part 11 STARe software option offers technical controls to support 21 CFR Part 11 compliance, including:

  • Password-controlled access
  • User-level management with roles for each user
  • Electronic records with file integrity
  • Electronic signatures
  • Properly logged audit trails

Join our live webinar to find out more about how you can maintain compliance for your thermal analysis system!

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