This is a recurring question on this board and in other venues- and I think you are addressing some vital points. If we take a history lesson, pre-late 1980s,...
Ray: You've unearthed a lot more than $0.02 worth, but we still have 3 distinct operations I don't see a distinct bridge between them in the near term. Vince ...
Scott, Do two things. 1. Read Part 11 very carefully (including the preface), especially about eSigs. See if your concept passes muster with the reg. 2. Ask...
I would suggest you do a third thing, which is challenge the business system that requires a signature for reviewing and approving a document. Sometimes...
Dux, Tom
tdux@...
Sep 6, 2007 5:20 pm
17098
Hello, We're looking at expanding the use of our validated Learning Management System next year by validating our AICC and SCORM capabilities. We are...
Hello Doug; Thank you very much for your prompt and detailed reply to my question. Very much appreciated. I am reccomending that my client develop a pop-up...
The act of a "wet signature" is to memorialize that an individual agrees with the terms and conditions of the document. It performs the function of acceptance....
Scott, A quick follow up. On part of the reg that I think a lot of folks fail to fully understand or implement is 11.300(d). (d) Use of transaction safeguards...
http://www.microsoft.com/technet/prodtechnol/windows2000serv/reskit/distrib/dscj_mcs_xxgl.mspx?mfr=true ... [Non-text portions of this message have been...
David; Thank you. The organization is rather small and there is considerable synergy/trust amongst the staff; yet I like to think like one of my mentors. My...
Doug; Thanks. This has been a cornerstone of the risk-based approach that we took on the assessment. Essentially we extended much of the organizations...
My colleague has told me it is impossible to find a Part 11 compliant digital fundus camera (retinal imaging). How does the FDA deal with situations where the...
Hi All, I have to elaborate two procedures in order to assure the validate state of my ERP software after the implementation one is Startup & Shutdown and the...
Raquel Couto
rcouto@...
Sep 15, 2007 7:04 pm
17109
Dear all, we received a very strange request from an investigator site on validation documentation of our Electronic Data Capture (EDC). The site wants a copy...
Juan, QA and Validation have distincts roles, as follows: QA is responsible for: Review and approve the execution of computer system validation documentation,...
Raquel Couto
rcouto@...
Sep 15, 2007 7:04 pm
17111
Any thoughts on current thinking for managment of controlled forms? i have been talking with many people over the past months about managing approved...
This may sound like a wierd question, but I am not very sohpisticated in part 11 or digital signature requirments. My question is related to the creation of a...
For many applications there are no technical solutions that can be considered compliant. In such cases you need to perform a risk assessment, and where needed,...
The only solution I can think of is to import it into a document management system as a "file" and establish that as a point for metadata collection. Most...
Some useful information can be found in the ITIL guides (www.itsmf.org) and there is a good book on such systems in the PDA bookstore (www.pda.org search for...
Adobe PDF (professional version) may be just the solution you are looking for. Siegfried ________________________________ From: 21cfrpart11@yahoogroups.com...
Hi Robyn, The short answer is no- on its own, Adobe Acrobat does not meet Part 11 requirements. Long answer: Adobe Acrobat has the capability of creating...
The investigator site is responsible for the source documents, which in EDC are stored electronically and therefore must be part 11 compliant. It is perfectly...
We have a system that currently allows sites to enter and submit Adverse Events via a web based system to a regulatory center. To submit a report, the...
We have a table on our website that our clients could send to all of their sites that shows how our system can be used in a compliant manner. Beyond that if...
Hi Ray, Not all the things you've said about Adobe are 100% correct. It is true that Adobe lets you to create your own self signed certificate and sign ...
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