White Paper

The Future Of The FDA: Operating In An "Electronic World"

By Daniel R. Matlis

FDA Approved

Over the past few years, the FDA and the industries it regulates have recognized the need for a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory and business operations.

This whitepaper discusses FDA transformational activities that promise to usher in a new era of electronic interactions between the agency and its constituents, and is based on primary research conducted by Axendia Inc. and commissioned by MasterControl.

The benefits of the FDA’s e-transformation could be “game changing”. Imagine conducting a label negotiation in real-time with FDA review staff, being able to cooperate and mark up documents in real time, or the possibility of reviewing SOPs and batch records electronically with an investigator. The agency’s move toward an electronic world where all regulated product information comes in electronically is already underway.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of ECM Connection? Subscribe today.

Subscribe to ECM Connection X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to ECM Connection