Agilent ChemStation B.04.01 Compliance with 21 CFR Part 11 Technical Note

About this manual

This document details the features of Agilent ChemStation (version B.04.01 or higher) combined with Agilent OpenLAB Enterprise Content Manager that enable adherence to 21 CFR Part 11 regulations regarding electronic records and signatures.

The integration utilizes the G2189BA ChemStation OpenLAB option to provide controls for system access, data transfer handling, and audit trails. It ensures accurate record copies, versioning, secure storage, and mandatory user authentication.

What's inside

• Introduction
• Applicable sections of 21 CFR Part 11
• Controls for Closed Systems
• System Validation (11.10a)
• Record Generation (11.10b)
• Record Protection and Retrieval (11.10c)
• System Access Control (11.10d)

Frequently asked questions

Does the system ensure accurate, reliable performance for electronic records?

Yes, Agilent develops its products according to a well-established product lifecycle concept and delivers fully qualified data handling systems.

How are electronic records protected from alteration?

Records are stored in Agilent OpenLAB ECM which uses byte-order dependent check sums at each file transfer operation to ensure validity.

Is system access limited to authorized individuals?

Yes, logging on requires a unique user ID and password combination, with access levels controlled by privileges assigned to users or groups.