21 CFR Part 11 Compliance Using STARe Thermal Analysis Software

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

Learn How STARe Thermal Analysis Software Supports FDA Compliance

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

The key objectives of 21 CFR Part 11 are:

  • Ensuring the generation of electronic records and electronic signatures that are trustworthy, reliable, and equivalent to paper records; and
  • The ability to detect and keep track of any alterations to electronic records.

In this webinar, we explain the scope and requirements of 21 CFR Part 11. We then explain the solutions offered by our STARe software. This includes the features of the 21 CFR Part 11 software option that allow users to work within a compliant system.

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 software 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; and
  • Properly logged audit trails.