New FDA Software Regulations 1/11/02

[John S. Gage]

The FDA's "Final Guidance" for software validation was issued on 1/11/02.  It contains the following statement:

"In addition, computer systems used to create, modify, and maintain electronic records
and to manage electronic signatures are also subject to the validation requirements.
(See 21 CFR §11.10(a).) Such computer systems must be validated to ensure accuracy, reliability,
consistent intended performance, and the ability to discern invalid or altered records."

Does this mean "electronic *patient* records"?  Obviously, I will address this question to the proper authorities. but the question certainly bears heavily on this list.

John