You might also want to look at www.docscorp.com as well as their product has some interesting features. Fraser (personal opinions etc) ... From: ...
Sims, Fraser
fsims@...
Feb 1, 2006 2:04 pm
14935
Anyone happen to hear recently when they plan on publishing the revision to Part 11? Last year it was "done and being held up by the publication process"; has...
Greetings, My client will be implementing a LIMS and content management system in the future, but until then, they are going to store GxP data on a Windows...
I did something almost exactly like this in a previous job (for QC lab data). We did go through to exercise of showing that the data was "write once" for the...
Hi, I belong to an Electronic Medical Record Vendor company. We need to know : 1. Who certifies if an EMR Vendor's product is CFR Part 11 compliant 2. Is there...
George Smith from FDA who's part of the FDA Part 11 committee will be at the GAMP Forum in Morristown, NJ on March 17, 2006 He'll provide update on the status...
Hi, I came across this article: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4312.pdf It says that FDA has revoked CFR Part 11. I am sure the article is outdated...
Does anyone know of any regs that speak specifically to compliance issues with productions like IM? I assume the same policies that apply to e-mail would...
Hi Group, We are using Oracle ERP suite of products ( Order management, Financials, Distribution) in our company. All the applications are validated. We are in...
Does anyone have any experience with validation of applications on Citrix Servers ? I am particularly keen to know from change contrl aspects like security...
Chris, I think you first have to demonstrate that your client's network is qualified. Then a documented Risk Analysis (could be part of the Strategy ...
Write a script to transfer the data. Validate the script. Transfer the data into a temp DB or file. Cleanup and review the transfered date. Run the same...
Hello, Does anyone know if there is a supplier of computer based training that is part 11 compliant? Ideally it would be located on a secure server and keep...
They did NOT revoke 21 CFR Part 11. They withdrew some of the guidances after they issued the Scope and Application guidance, specifically: "We are also...
No, Part 11 has not been revoked. A guidance document was issued in August 2003. As part of that process, the previous guidance documents were withdrawn. ...
I am on the CCHIT (Certification Committee for Health Information Technology). This group has been tasked by the Bush administration via Dr. Brailer's office...
David Winn
dlwinn@...
Feb 6, 2006 2:05 pm
14951
Not quite! The various guidances were suspended (and still are), but the regulation itself was left in effect. Mark ... From: 21cfrpart11@yahoogroups.com...
You can only determine Part 11 compatibility. Compliance can only be done thru software, hardware, SOP's and people. A vendor can only make their software...
As of mid-January it was still a draft, and the Part 11 committee hadn't sent it to the lawyers to approve yet. The committee is targeting Spring of this year...
Phil Kibitt
PhilK@...
Feb 7, 2006 5:00 pm
14954
Is there any electronic system available out there for re- qualification schedule? We need a system to schedule our process re- qualification schedule....
Hi: Valgenesis provide a revalidation schedule together with their validation management system. I have also heard from people using Outlook and MAXIMO...
Thanks for the information. Any one has experience with Blue Mountain for re-qualification? it is again another PM tool. I heard about Valgenesis through PDA....
Yes, we have a system that manage all the validation activities needed for bringing a system into the validated state and also keep that system in that state...
Piet Vervoort (Rescop)
p.vervoort@...
Feb 7, 2006 11:33 pm
14959
Do you need to validate the Out look? I hope the revalidation scheduler may not require Part 11 compliance, but FDA may expect at least the validation...
We use a program called Paradigm. It is a DMS that also has a d'base and scheduler. We use the latter for preventative maint and calbration reminders. ...
Andrew Gibson
agibson@...
Feb 8, 2006 2:02 pm
14961
We have used another calibration tool for re-qualification schedule. This was just a scheduler to create re-qualification calendar. Recently we have...
Validation is a risk business. What is the risk of Outlook failing to do its core task when it has been in the marketplace for many years and has been used by...
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