The audit trail regulatory requirements from 21 CFR 11 and EU GMP Annex 11 are compared and contrasted.
Table 1: FDA and EU Audit Trail requirements from 21 CFR 11 and Annex 11 21 CFR 11 EU GMP Annex 11, [section]11.
As the name suggests, user support involves using audit trail data to support user activities within ETEs.
This category refers to the use of audit trail data to drive adaptive decision logic within the target ETE.
Actually, if you understand the underlying architecture of the business system being deployed, building an audit trail
system is relatively straightforward and the prices that you pay for these audit trail
systems are correspondingly reasonable.
The resulting audit trail
provides trusted evidence for IT audit requirements.
In addition, the appliance tracks and logs all administrative password requests, releases and activity for any PowerKeeper managed system, and creates an audit trail
from which various reports can be generated.
Change-detection techniques include audit trails
-- such as byte count, hash-control totals and formula-difference locators, all of which are explained later.
Site Manager's EZ-Configure simplifies and improves configuration management for centrally managed, geographically dispersed router internetworks with configuration profiles, configuration reports, and configuration audit trails
Facing critical security issues such as access control, regulatory compliance and resource provisioning, healthcare providers are increasingly investing in technologies that automate the manual processes involved with providing quick and secure access to applications and information, while supplying audit trails
that ensure compliance with government regulations.
New solutions deliver trustworthy verifiable audit trails
The certification of McLaren's Enterprise Engineer to interoperate with our SmartRecovery product provides the only end-to-end solution that allows engineering practices to preserve the documents and audit trails
generated in Enterprise Engineer," said Wayne Crandall, CEO at CYA Technologies.