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Home Biblioteca de expertos Videos 21 CFR Part 11 Compliance for Thermal Analysis
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21 CFR Part 11 Compliance for Thermal Analysis

Vídeo

This 4-Part Video Series Introduces STARe Software's 21 CFR Part 11 Option

The CFR option in thermal analysis STARe software provides the mandatory technical controls for compliance with 21 CFR Part 11 regulations on access control, user rights, electronic records, electronic signatures and audit trails.

Part 1: Access Control

To guarantee that all work in a thermal analysis computerized system is attributed to a single individual, each user must have a unique user identity for logging on. Part 1 of the video series covers this topic of how to best use the STARe 21 CFR 11 software option for data integrity in thermal analysis.

This video shows you how to create unique user accounts that are password protected. Additionally, passwords and user policies can be defined according to the security requirements of your organizations.

Part 2: User Rights

Managing user rights in the STARe software reduces the risk of data manipulation by restricting users to areas of the system that allow them to perform their job functions. Part 2 of the video series covers this topic and mentions how to best use the STARe 21 CFR 11 software option for data integrity in thermal analysis.

This video shows you how to create new user roles, to which you can assign any number of available access rights to an employee.

Part 3: Electronic Signatures

Electronic signatures in STARe software meet the requirements of 21 CFR Part 11 to ensure secure access to original data, which cannot be removed, copied or transferred. Part 3 of the video series covers the topic of how to best use the STARe 21 CFR 11 software option for data integrity in thermal analysis.

This video shows you how to assign electronic signatures to data records in STARe software.

Part 4: Audit Trail

The built-in audit trail functionality in STARe software generates complete audit trail entries, which include:

  • Links to the corresponding records
  • User IDs
  • Original and new values
  • Reasons for change
  • Date and time stamps

Part 4 of the series is on how to make the best use of the STARe 21 CFR 11 software option for data integrity in thermal analysis. This video shows you how to activate and review audit trails in STARe software.