Persons must use secure, computer-generated, time stamped
audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
This has been interpreted in the Able Laboratories 483 (9) and a number of warning letters (10,11) that
audit trails in chromatography data systems should be reviewed.
The type of
audit trails tracked in the solution I represent, Microsoft Dynamics, are quickly emerging as a must-have for today's manufacturing professional.
You really do need to be methodical when you are building up to
audit trails.
The fourth role of
audit trails defined by Misanchuk and Schwier (1992), counselling and advising, represents one of a number of related roles of
audit trails that the authors placed within a second domain-that of "user support.
The data integrity, access controls, and
audit trails provided by digital certificates are not available through firewalls, passwords, and VPNs.
These
audit trails can be printed by clicking on File, Print and selecting Summary Information in the Print What box.
Manufacturing software helps pharmaceutical companies achieve 21 CFR Part 11 compliance through: centralized password and user management, point verification, centralized storage of e-records and
audit trails, and simplest remediation of existing systems.
Is there an
audit trail to show changes since the last version?
