This document introduces the application of Agilent ChemStation Plus Security Pack and NuGenesis ARCHIVE as a comprehensive lab-wide solution for 21 CFR Part 11 compliance. Agilent ChemStation Plus Security Pack software provides full compliance support for data acquisition, result calculation, and storage of raw and meta data. NuGenesis ARCHIVE software is an important part of many companies' overall compliance solution, providing an automated backup, archiving, and cataloging system for all software-based instruments in a lab or enterprise.
Agilent Technologies presents an application note detailing the capabilities of its ChemStation Plus Security Pack and NuGenesis ARCHIVE software. These tools are designed to help pharmaceutical and analytical laboratories meet specific data handling requirements set by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 11 regulations.
The document explains how ChemStation Plus Security Pack ensures system and data security through access control, session locks, and advanced user management. It also highlights features for maintaining data integrity and generating audit trails that track all activities related to data acquisition and result calculation.
The software helps laboratories comply with the U.S. Food and Drug Administration's (FDA) 21 CFR Part 11 regulations.
NuGenesis ARCHIVE interfaces with CD jukeboxes, Zip drives, JAZ drives, hard disks, RAID drives, and magneto optical media.
The database provides a link between raw data, processed results, and methods, ensuring no data is ever overwritten by storing reanalysis copies as revisions.