http://tech.groups.yahoo.com/group/21cfrpart11/ A forum for issues and questions regardi Wed, 08 Jul 2009 18:38:46 GMT sara.camden http://tech.groups.yahoo.com/group/21cfrpart11/message/19513 http://tech.groups.yahoo.com/group/21cfrpart11/message/19513 Hi all, I know this is a little off topic, but I am working on a research project on the med device industry's thoughts as to the impact of the impending Wed, 08 Jul 2009 15:33:06 GMT Graham Tinsley http://tech.groups.yahoo.com/group/21cfrpart11/message/19512 http://tech.groups.yahoo.com/group/21cfrpart11/message/19512 That is certainly possible. There are quite a few interested parties involved and the primary relationship would seem to be between physician and patient, Wed, 08 Jul 2009 15:32:03 GMT Schmitt, Siegfried http://tech.groups.yahoo.com/group/21cfrpart11/message/19511 http://tech.groups.yahoo.com/group/21cfrpart11/message/19511 REMS are mostly written using MS Word, so it's difficult to see where Part 11 comes in Siegfried ________________________________ From: Wed, 08 Jul 2009 13:05:29 GMT Acosta_Harry http://tech.groups.yahoo.com/group/21cfrpart11/message/19510 http://tech.groups.yahoo.com/group/21cfrpart11/message/19510 Graham, can it be that the FDA is referring to the Part 11 compliance of a computerized system used to monitor post-marketing REMS and maybe HIPAA for Tue, 07 Jul 2009 16:05:40 GMT Graham Tinsley http://tech.groups.yahoo.com/group/21cfrpart11/message/19509 http://tech.groups.yahoo.com/group/21cfrpart11/message/19509 Unless you are able to provide more specific examples (e.g. what REMS program, which supporting system?) then from the information you have provided I would Tue, 07 Jul 2009 14:05:05 GMT James Spangler http://tech.groups.yahoo.com/group/21cfrpart11/message/19508 http://tech.groups.yahoo.com/group/21cfrpart11/message/19508 I understand what you are saying, however, in the FDA appilcations letters I have reviewed, none of them mention being 21 CFR Part 11 compliant.  However, in Tue, 07 Jul 2009 14:03:34 GMT James Spangler http://tech.groups.yahoo.com/group/21cfrpart11/message/19507 http://tech.groups.yahoo.com/group/21cfrpart11/message/19507 I understand what you are saying, however, in the FDA appilcations letters I have reviewed, none of them mention being 21 CFR Part 11 compliant.  However, in Thu, 02 Jul 2009 18:48:25 GMT Graham Tinsley http://tech.groups.yahoo.com/group/21cfrpart11/message/19506 http://tech.groups.yahoo.com/group/21cfrpart11/message/19506 One is an apple, the other is an orange? One is a set of regulations for compliance, specifically covering electronic records and signatures. The other is a Thu, 02 Jul 2009 17:00:39 GMT Greg Ventura http://tech.groups.yahoo.com/group/21cfrpart11/message/19505 http://tech.groups.yahoo.com/group/21cfrpart11/message/19505 I imagine that you would evaluate whether the system you are dealing needs to be compliant. If you need to be compliant then you would evaluate what you need Thu, 02 Jul 2009 16:51:46 GMT jspan1971 http://tech.groups.yahoo.com/group/21cfrpart11/message/19504 http://tech.groups.yahoo.com/group/21cfrpart11/message/19504 I am trying to understand exactly what the impact of 21 CFR Part 11 on REMS (Risk Evaluation and Mitigation Strategies) is. I have reviewed several REMS Thu, 25 Jun 2009 12:38:24 GMT Sigfrid Dusci http://tech.groups.yahoo.com/group/21cfrpart11/message/19503 http://tech.groups.yahoo.com/group/21cfrpart11/message/19503 Hello all, I'm working on my first FileMaker (FM9 + IWP) project and I'd like to know if anyone has any specific suggestions about how to validate the Wed, 24 Jun 2009 18:30:27 GMT ffredersen http://tech.groups.yahoo.com/group/21cfrpart11/message/19502 http://tech.groups.yahoo.com/group/21cfrpart11/message/19502 Thanks all. Very good information from everyone. Interesting note, I went to the company that did the ISO certification for the software vendor I'm looking Tue, 23 Jun 2009 15:19:42 GMT James Stafford http://tech.groups.yahoo.com/group/21cfrpart11/message/19501 http://tech.groups.yahoo.com/group/21cfrpart11/message/19501 Agreed that the trick is to read the scope of certification and the generic nature of ISO 9001 certification. I recall a company touting their ISO Tue, 23 Jun 2009 13:16:26 GMT Schmitt, Siegfried http://tech.groups.yahoo.com/group/21cfrpart11/message/19500 http://tech.groups.yahoo.com/group/21cfrpart11/message/19500 The trick is to read what is not on the certificate, as these will only detail the parts of the company that are compliant, but omit any that aren't. I knew a Tue, 23 Jun 2009 13:16:19 GMT J B http://tech.groups.yahoo.com/group/21cfrpart11/message/19499 http://tech.groups.yahoo.com/group/21cfrpart11/message/19499 Hello,   In addition to what already mentioned:   - Ask the vendor for names (referrals) about any previous software buyers (US buyers) - Analyzed list