FDA Compliance Policy Guide

In August 1999, the FDA issued the Compliance Policy Guide, which gives direction to investigators regarding Part 11.

This document specifies that companies need to have a Compliance Plan in place to show how systems will be brought into compliance. Additionally, companies need to show progress against this plan.

The document also states that:

• Procedural controls should already be in place
• Technical controls (e.g. new software) may take longer to install on older systems (often called legacy systems)