What’s in this guide

This document details how to configure each feature set of the FDA Module, such as the audit log and electronic signatures.

The appendices contain additional useful information to help you deploy the FDA Module:

• An explanation of how the FDA Module addresses U.S. Code of Federal Regulations Title 21 Part 11 requirements
• Descriptions of the security privileges added to Meridian Enterprise by the FDA Module.

Standard Meridian Enterprise functionality is not described; this document assumes that the reader is already familiar with Meridian Enterprise configuration. For that information, see the BlueCielo Meridian Enterprise Configuration Guide.