In theory I think it can apply to record in the sense of a database record (e.g. a tuple on a data table in a relational database), but I haven't heard the FDA's overall guiding principle - you ned that for sure. If I were implementing software to comply with this requirement on its face value as you have put it here, I would monitor changes on the most fundamental levels of the system - at the record/file level. If you monitor and report on changes to data files, databases, etc . . . in an EMR application, it follows that you monitor changes in the patient data that are stored in those mechanisms. The trick of course is building the functionality to retrieve the change information (a user interface). Richard Schilling Web Integration Programmer Affiliated Health Services Mount Vernon, WA http://www.affiliatedhealth.org <http://www.affiliatedhealth.org>
-----Original Message----- From: John S. Gage [mailto:[EMAIL PROTECTED] Sent: Tuesday, January 29, 2002 2:16 PM To: openhealth-list-minoru-development.com; Debian Med Project List Subject: New FDA Software Regulations 1/11/02 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 ยง11.10(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
