Yes, the point being that people have not necessarily done this "in the past" before going to the need for electronic signatures. Thus, it requires a change...
Orlando and the rest of the forum already mentioned very important points regarding this topic. I have one question for you, if you validated your process to...
Hi all, I would like to know what you think is required to when a company migrate from NT4 domain to Windows 2003 Active Directory. I think that a migration...
Dear Patrick, most of the pharmacautical companies we working for have not qualified or resp. validated their AD on Windows 2003. You should first conduct a...
Patrick, Your approach seems generally okay but the one critical piece missing is a risk assessment. A risk assessment will not only guide the nuts-and-bolts...
Validating the scanning process? Let me put it in another words, Do you validate the microfiche process as a mean to archive documents? This is the ...
We did not qualify the migration but the implementation of AD, which is really straightforward. There is no need for validation (see e.g. GAMP 4) Having a...
Schmitt, Siegfried (G...
siegfried.schmitt@...
May 3, 2005 12:29 pm
13651
Hi Orlando I knew you were going to scream with the statement of validating the scanning process :) Anyway, I agree with your point, the SOP is the way to go...
Patrick, if it is not a "GxP Server" then I would say is over the top otherwise I think you are being cautious but need to relax a bit. First, do the Risk...
What if you plan on using AD2003 as your basis for logins, identities and electronic signatures within the company (both regulated and non-regulated)? Greg ......
Hi All, Can anyone please suggest best sites where i can find computer system validation jobs. Thanks reddy MODERATOR NOTE: VENDORS RESPOND PRIVATELY....
Controlling through SOP would be an ideal way. But if there is a system to route the scanned documents (converted into a PDF format) for approval is not a bad...
Reddy, I always found Medzilla.com, Dice.Com, and Monster.Com to have the most listings for csv positions. There are also a lot of placement agencies on those...
... wrote: Greg you got it right. This is our case. Some applications are using AD2003 as part of their software architecture and when some applications...
another possibility of routing is a common repository in which all entities go and load the document. Orlando Lopez Director, WW IM Compliance Cordis a Johnson...
We are a medical device company that creates software that works with the device. The software is developed using the likes of Microsoft's SourceSafe, Visual...
Dear colleague, first take a look on the draft ISO/IEC Norm DIS 62304 (Draft - last votings on 2005-05-06) "Medical Device Software - Software Life Cycle...
I work for a company that has its own implementation of the 21CFR part 11 requirements. The portions that are implemented are User Authentication, Auditing,...
Here is a recent one that was brought up in the last PEERS meeting. There are a few more around, generally found in the medical device arena. From what I hear...
Thanks Derek for providing that. It appears to me that my this EMR system is some application that the investigator bought or built themselves. Why would they...
CV, An implementation of part 11 for what? Document management? Chromatography? Spreadsheets? CAPA? E-submissions? You need to be specific on what the system...
Hi everybody, I would like to get feedback from all of you who have a Quality Management Software available (CATSweb, Trackwise, ETQ, Master Control, etc.) No...
Hi Greg, The EMR system is most likely one of the commercial ones. Docs are very interested in these; my pediatrician got one for his practice and absolutely...
Juan We use Master Control for SOPs It is a cheaper alternative to Documentum. Not as robust but it works for our purposes. Tom ... Thomas Duff Associate...
Thanks Derek. If the vendor does not have something they can provide to the doctor then I guess they have a problem. I am not all that familiar with an EMR...
Hi, I wanted to get some feedback on the issue of how long do we need to keep documentation related to changes and validation of a system. The current system X...
Greg, Derek I remember working on the validation of a blood testing where the automatic pipetting was proven to be substantially more accurate than the...
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