The document provides information about testo Comfort Software CFR 4
This manual explains how to install and use testo Comfort Software CFR 4, a tool designed for data logging and analysis compliant with 21 CFR Part 11. It covers system requirements, user access control, electronic signatures, and audit trails. The software integrates with approved Testo data loggers and uses Windows security for user management. It is intended for organizations needing FDA-compliant electronic records.
The manual also includes guidance on creating standard operating procedures (SOPs) and training users to ensure compliance. It references specific Testo instruments like testostor 171 and testo 174, and explains how the software supports data integrity and traceability required by 21 CFR Part 11.
| Intended Purpose | Saving, reading out and analysing individual readings and measurement series. |
|---|---|
| Compliance | 21 CFR Part 11 |
| Security System | Windows® operating system security mechanisms |
Section 21 of the Code of Federal Regulations (CFR) is a part of the laws and regulations passed by the government of the United States of America in connection with the Food and Drug Administration (FDA).
It serves the purpose of saving, reading out and analysing individual readings and measurement series.
testostor 171, testo 174, testo 175, testo 176, testo 177, testo 184.
It uses the security mechanisms of the Windows® operating systems.