Audit Trails Compliance in 3 Simple Steps

The Problem

"Did you audit trail that?" is the question on every inspector's mind. FDA's expectations for data integrity have evolved, and simply having an audit trail isn't enough—you must review it, understand it, and ensure it captures the right actions.

Example: You have a computerized system. Do you know exactly which data fields must be captured in the audit trail to satisfy ALCOA+ principles?

Here's how KeyPedia helps you ensure data integrity: Just ask KeyPedia to explain the FDA's current position on audit trail implementation and management.

Why? Because KeyPedia's input is fed from guidance documents, FDA regulations, good practices, FDA-483s, and Warning Letters.

1. Ask

Ask KeyPedia: "What is FDA's position regarding the implementation and management of audit trails?"

2. Review

KeyPedia outlines the requirements for secure, time-stamped, and comprehensive records, linking directly to 21 CFR Part 11 and data integrity guidance. See the complete KeyPedia response in Dan's LinkedIn post below.

3. Implement

Use the guidance to gap-assess your current systems and audit trail review procedures.

From data gaps to complete integrity, see how KeyPedia helps you protect your records:

Engage with Dan's LinkedIn post →