Originally Published MX January/February 2005

IT IN HEALTHCARE

FDA rules for electronic compliance documents are headed toward a major overhaul.

Christina Elston

Once upon a time, medical device companies could expect to make their manufacturing processes more efficient by using the same real-time management systems used by other types of companies. "In the old world, medical product companies could use the same systems that were being used in other industries, as long as they paid close attention to the tracking and control of materials, to good manufacturing practices (GMPs), and to their ability to support recalls," says Bill Burke, president and CEO of Merit Solutions (Wheaton, IL).

But that was before FDA went electronic.

In 1997, FDA issued a new regulation designed to make it easier for manufacturers to use wholly electronic methods of maintaining and approving compliance-related records.¹ The new regulation, 21 CFR 11—commonly referred to as Part 11—was a good idea. But it soon became clear that FDA had no idea how to implement it.