Dan Waters
dwaters at usinternet.com
Tue Apr 8 14:52:42 CDT 2003
Jim, http://www.fda.gov/ora/compliance_ref/part11/ This is the web site from the FDA that has all the official information. It's a lot to wade through, and the requirements seem strict. Your company should have a Regulatory Manager who is or should be familiar with these requirements. AFAIK, Access alone does not meet the security requirements, but an Access FE with a SQL BE will. The difficult requirement is that the user must re-enter the user name and a password (not necessarily the same as the network log-in password) immediately prior to making an electronic 'signature'. There may also be a requirement for an audit trail of all the changes made in a record. Also, the strictness of the rules can vary depending on the product or service. Good Luck! Dan Waters -----Original Message----- From: accessd-bounces at databaseadvisors.com [mailto:accessd-bounces at databaseadvisors.com] On Behalf Of Jim DeMarco Sent: Tuesday, April 08, 2003 12:20 PM To: accessd at databaseadvisors.com Subject: [AccessD] Slightly OT:Electronic Medical Record Does anyone on this list (in the health care industry) have any familiarity with these or use them? Thanks, Jim DeMarco Director of Product Development HealthSource/Hudson Health Plan -----Original Message----- From: Mwp.Reid at Queens-Belfast.AC.UK [mailto:Mwp.Reid at Queens-Belfast.AC.UK] Sent: Tuesday, April 08, 2003 1:54 PM To: accessd at databaseadvisors.com Subject: [AccessD] OT Smart Tags Anyone know of any security issues surrounding the use of Smart Tags with particular reference to thier use in Access. Martin _______________________________________________ AccessD mailing list AccessD at databaseadvisors.com http://databaseadvisors.com/mailman/listinfo/accessd Website: http://www.databaseadvisors.com ************************************************************************ *********** "This electronic message is intended to be for the use only of the named recipient, and may contain information from Hudson Health Plan (HHP) that is confidential or privileged. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or use of the contents of this message is strictly prohibited. If you have received this message in error or are not the named recipient, please notify us immediately, either by contacting the sender at the electronic mail address noted above or calling HHP at (914) 631-1611. If you are not the intended recipient, please do not forward this email to anyone, and delete and destroy all copies of this message. Thank You". ************************************************************************ *********** _______________________________________________ AccessD mailing list AccessD at databaseadvisors.com http://databaseadvisors.com/mailman/listinfo/accessd Website: http://www.databaseadvisors.com