21 CFR Part 11 Compliance with Thermal Analysis Software
Know How

21 CFR Part 11 Compliance with Thermal Analysis Software

Know How

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.

The STARe software solution

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 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
21 CFR Part 11 Compliance
20 CFR Part 11 FAQs
20 CFR Part 11 FAQs
Data Integrity Software Option
Data Integrity Software Option

CFR software option: How-to video collection

21 CFR Part 11 FAQs

This document addresses the main questions regarding 21 CFR Part 11 compliance.

Data integrity software option

Data management best practices for non-regulated industries.

Thermal Analsis STARe Software
Thermal Analsis STARe Software
Thermal Analsis Validation Handbook
Thermal Analsis Validation Handbook
Validation in Thermal Analysis Webinar
Validation in Thermal Analysis Webinar
Good Thermal Analysis Practice
Good Thermal Analysis Practice

STAReX™ Connectivity

Eliminate transcription errors with electronic transfer of balance data from LabX to STARe.

Validation Handbook

From IQ/OQ to SW and method validation.

Validation Webinar

Online training – free-of-charge!

GTAP

Safeguarding the entire lifecycle of your investment

Thermal Analysis Services
Thermal Analysis Services
Thermal Analysis Tips and Hints
Thermal Analysis Tips and Hints
Quality Control by Thermal Analsis Webinar
Quality Control by Thermal Analsis Webinar
Calibration and Adjustment in Thermal Analysis Webinar
Calibration and Adjustment in Thermal Analysis Webinar

Training possibilities
 

Be it classroom sessions or free-of-charge online trainings, we offer various programs to fit your schedule and requirements

Tips and Hints
 

Optimize your thermal analysis experiments

Quality Control by Thermal Analysis Webinar

Ensure high product quality with the proper TA experiments

Quality Control by Thermal Analysis Webinar

A prerequisite for accurate results

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