RE: New FDA Software Regulations 1/11/02
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:jgage@epo.som.sunysb.edu]
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 §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
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