This document describes how to use Agilent ChemStation to ensure that UV-visible spectroscopy data complies with FDA 21 CFR Part 11.
This document outlines how the Agilent ChemStation software, specifically when used with the advanced or dissolution mode and security pack, helps pharmaceutical companies comply with FDA 21 CFR Part 11 regulations. The solution is designed for closed systems and addresses key requirements including data security, data integrity, and audit traceability.
The text details the implementation of user access control via Windows NT, the protection of raw and meta data to ensure reproducibility, and the creation of audit trails. It also describes the electronic signature process and provides a feature comparison table showing which modes (Standard, Advanced, Dissolution) support specific compliance features like raw data protection and mandatory log-on.
| System Type | Closed system only |
|---|---|
| User Identification Method | Unique user ID and personal secret password |
| Password Management | Windows NT administrator manages users, not passwords |
Full support requires the advanced and/or dissolution-testing mode combined with the security pack.
It protects raw and meta data from unauthorized modification and links them to results to enable reproduction of original data during an audit.
No, result files are protected against manipulation or deletion using Windows NT file access permissions once created.