This document discusses the combination of Agilent ICP-MS ChemStation and Agilent OpenLAB ECM to comply with 21 CFR Part 11. The User Access Control Pack enables system access control and audit trail functionality, while Agilent OpenLAB ECM ensures secure record keeping and data archival. This solution has been successfully deployed at many leading life sciences companies to meet compliance requirements for 21 CFR Part 11.
This document examines the sections of 21 CFR Part 11 and provides recommended remediation approaches using the Agilent ICP-MS ChemStation with the User Access Control Pack enabled. It describes how the system ensures electronic records are reliable, authentic, and maintained with high integrity.
Yes, entries in the OpenLAB ECM audit trail are non-editable, non-deletable, and removing records from the database does not affect existing entries in the audit trail.
Each user is identified by a unique user-ID/password combination, and access is controlled through privileges and roles assigned to individual users or groups of users.