This document introduces the 21 CFR Part 11 compliance features of the Agilent MicroLab FTIR software, including logon security, data security, electronic signature capability, audit trail capability and validation of system performance.
Agilent MicroLab FTIR Software is designed to meet the requirements of US Food and Drug Administration (FDA) regulations under Title 21 Code of Federal Regulations Part 11. The software provides specific features such as login security, data security, electronic signature capabilities, and audit trail functionality to ensure that electronic records are trustworthy and equivalent to handwritten signatures on paper media.
The document details the implementation of user-level permissions to restrict access based on roles like Technician, Service Engineer, Developer, or Administrator. It explains how the software protects data integrity by preventing unauthorized modifications and overwriting, automatically saving all collected data with unique filenames, and issuing warnings if tampering is detected. This manual is written in Japanese.
The software allows assigning permission levels such as Technician, Service Engineer, Developer, and Administrator to define specific actions.
The software automatically saves all collected data and prevents overwriting of data files with unique filename formats.
The software tracks changes made to the file, and marks the signature as expired if the data is reprocessed or corrected.