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