Introducing the Meridian FDA Module

The BlueCielo Meridian FDA Module is an optional module for BlueCielo Meridian Enterprise that adds Title 21 CFR Part 11 technical controls to the already powerful technical document management system of BlueCielo Meridian Enterprise. The FDA Module provides the advanced document control tools needed by pharmaceutical companies throughout the document creation, review, approval, revision, and archive processes to make FDA compliance easier.

The FDA Module provides the following main features:

• Audit log
• Authenticated access
• Electronic signatures