A sensible approach is to describe the outsourcing process, which includes the writing of SLAs in an SOP that will bear the QA signature. The SLAs will then...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jun 1, 2007 7:46 am
16852
Our organization is considering a separate testing team for functional testing of IT systems. This would be part of our implementation of automated testing...
QA sign off is not required, however you should ask for SAS-70 report from your service provider and make references in your SLA. SAS-70 should also be given...
I agree with Siegfried. The SOP should account for the types of services being provided and the associated risk. Some services have greater impact on...
Maybe I am missing the intent of your post, but I do not understand how records "essential to demonstrate compliance with FDA Predicate Rules" should be...
Part 11 requires verification of identity. How is this being done in distributed applications (for example at a clinical site when the application is 'owned'...
The impression I have always had of this is that it has to be a procedure. You have to verify the identity of a user before you give them a userid and...
Dave, in my specific situation for my site, I lead a support group called Quality I/S Support that is dedicated to full SDLC of configurable COTS software...
everybody is mantaining a very conservative approach on eSource. Majority of the sites are still recording source on paper and then transcribe them into the...
Isn't it adding more unnecessary work? I mean, if there is an employee on the company with company provided ID, and the supervisor, or manager signs a formal...
I agree with you, but the specific scenario that "validateforperformance" is talking about is distributed systems where people such as investigators are using...
validateforperformance, A lot of folks use the credentialling services offered under the SAFE(tm) model. It's a standards-based consortium. Check it out at: ...
Our software generates reports in Microsoft Word and Excel. I'm working on making our software meet requirements to fit into a Part 11 compliant environment. ...
Oh! OK, I just my answer was based on a local scope. In that case I think that, "again", a risk based approach would be suitable. ... From: Greg Ventura...
I am splitting hairs but then that's essentially what the FDA 2003 Guidance on Scope and Application advised us to do. Part 11 only applies to records...
We use PKI. It is fully compliant and is also a technology which has been around for at least 10-15 years. Here's the Wikipedia description: "...a public key...
We use the CoSign solution integrated into our MOSS 2007 based EDM/ECM application. There were some issues but CoSign engineers were very supportive in working...
Guys, I accept that this is a useful and interesting discussion, but this posting now runs to 15 pages!! Can we do a bit of editing please?? Thanks Dave ...
Perhaps the real issue is the regulations themselves. GMP only requires that you have the training to do the job. GLP requires that you have training records...
Within todays regulatory / political environment, our global company is dealing with more and more regulations that impact computerized systems. As an...
A few others more security related, not really applicable to most pharma companies: - GLBA (Gramm-Leach-Bliley Act) - FACTA (Fair and Accurate Credit...
EPA CROMERR (US) Japan has a part 11 regulation In the US, each state may have laws that apply to clinical trials Payment Card Industry data security standard...
<OT humor> Uhhhhmmmmm...great suggestion...any reason _you_ didn't snip the thread? ;-) </OT humor> FWIW, the request to trim threads recurs in this forum (and...
Mike I think it would be wise to offer a little more than simply 'placing the responsibility on the user'. There are possibly a few simple optional controls...
... this is exactly what I was wondering about and am in a spot of "how far do I go" with these reports. So your list helps. A few others I was considering *...
Attached is some information I got second hand, but I thought it might elicit more conversation from the group. "SOCRA and FDA's Chicago District Office...
Not Exactly, E-signature is a process for makes the equivalent of autograph sign used when you send or receive official document. This process can be made...
Ok thanks. Well what about E-mails between a doctor and a patient? Are the E-mails with signatures at bottom considered valid forms of documentation? Also,...
Hi Rob, I respectfully disagree all around. ... at ... However, two of the three the examples given in the guidance explicitly mention data at the clinical...
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