Who should read this guide

This guide is intended for use by drafters, designers, engineers, and anyone else who works with controlled documents in accordance with U.S. Code of Federal Regulations Title 21 Part 11. Those features that are native to Meridian Enterprise are beyond the scope of this documentation and are described in the BlueCielo Meridian Enterprise User’s Guide provided with Meridian Enterprise. Readers should be familiar with, and have experience in:

• General personal computing concepts
• The Windows® operating system, including its use in a network environment
• BlueCielo Meridian Enterprise client applications
• Using various document types in everyday business situations
• Basic document control methodologies such as revision control

Much effort has gone into making the FDA Module easy and intuitive to use. This guide assumes, however, that you have attended a training class on Meridian Enterprise to become familiar with its operation or have significant experience with the program.