21 CFR Part 11 Compliance for Thermal Analysis
دليل

21 CFR Part 11 Compliance for Thermal Analysis

دليل

The CFR Option in STARe Software Provides the Technical Controls for 21 CFR Part 11 Compliance

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:

21 CFR Part 11 Compliance for Thermal Analysis

 

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