Established back in 1997, FDA's 21 CFR Part 11 compliance guidelines specify the system elements, controls, and procedures that are necessary to ensure the trustworthiness of electronically stored records.
21 Cfr Part 11 Compliance for Thermal Analysis
GMP and 21 CFR Part 11 compliance means providing additional security to the data management system. The STARe software is designed as a closed system, more precisely an environment in which system access is controlled by persons who are responsible for the content of electronic records present on the system.
As detailed in our 21 CFR Part 11 datasheet, STARe software supports 21 CFR Part 11 compliance for thermal analysis with password access-control to the application, user-rights for each user-level, file integrity with electronic records, properly logged audit trails and electronic signatures.
STARe offers two software options for data integrity tailored to different needs and requirements:
Related Links
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21 CFR Part 11 FAQs
This document addresses the main questions regarding 21 CFR Part 11 compliance.
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Data integrity software option
Data management best practices for non-regulated industries.
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STAReX™ Connectivity
Eliminate transcription errors with electronic transfer of balance data from LabX to STARe.
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Training possibilities
Be it classroom sessions or free-of-charge online trainings, we offer various programs to fit your schedule and requirements
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Quality Control by Thermal Analysis Webinar
Ensure high product quality with the proper TA experiments
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Calibration and adjustment in thermal analysis
A prerequisite for accurate results
