The document called "Federal Register dated March 20, 1997" is what we refer to as "The Regulation". The Code of Federal Regulations (CFR) is a large body of...
HI Sarika, Here is the link: http://www.fda.gov/ora/compliance_ref/part11/ So, are you working right now for a part 11 compliance team as a compliance...
Hello Everyone: I am thinking of attending a couple of conferences held by ISPE in VA called 21 CFR Part 11 - Six Years Later and Principles and Applications...
I have attended several of the ISPE courses and seminars. The courses are more intense on the subject material being presented than a seminar is, but I have...
We are new to electronic submission. Is there any tool availble for e- submission to agency?. We are looking for an automated tool with change control and to...
Hi Vinay, Well I am actually working for a pharma company as process specialist for their IT division. And my role involves ensuring the CSV for them. And also...
Hi Greg, Thanks for your inputs. They are of great help. Now I am much more clear about same. -Sarika ... we ... is a ... regarding ... regulations ... ...
Yes, I would recommend the ISPE conferences. I attended the one just recently in Brussels and was impressed with the content, the speakers and the course...
lbryans@...
Jun 2, 2004 11:58 am
11635
Hi- Can you please tell me a nice site that gives the FDA"s stance on paper vs. electronic, and their various and sundry opinions? Thanks- C Sarika...
Hi Sarika, Greg is absolutely right. John Murray of the FDA said this at the recent IVT conference: While usually the regulations are the master and guidance...
ludwig_huber@...
Jun 3, 2004 1:21 pm
11637
I have also attended the one on Principles and Applications of GAMP4. I found it extremely useful and you also get to bounce idea off other participants etc....
Fletcher, Debbie
debbie.fletcher@...
Jun 3, 2004 1:24 pm
11638
Hi All. We are in the midst of some turmoil at my company over the introduction of SAS. To date, all of our data has been handled by CROs. However, in a cost...
...the FDA web-site? Laura ... From: Ami Canzano [mailto:canzanoa@...] Sent: 02 June 2004 13:32 To: 21cfrpart11@yahoogroups.com Subject: Re:...
lbryans@...
Jun 3, 2004 3:07 pm
11641
1. Something to keep in mind is that SAS comes with various tests that you can run yourself. For example, if SAS is installed in the D:\SAS8 directory, the...
My take on your questions (bear in mind, just my personal opinions): 1. The SAS programmer wanted to conduct IQ/OQ to verify the functionality of SAS. We agree...
Hi Kim, We are a small pharma and did an IQ/OQ on SAS. It is easy to verify the installation using basic IQ requirements. We used SAS routines to verify the...
Kim, My take on your questions: 1. You need do an IQ on your SAS installation, but not an OQ. SAS provides tools to help in the IQ, which you'd need to...
Tappe, David
david_tappe@...
Jun 3, 2004 3:08 pm
11645
Hi Kim, To declare an interest, I work for SAS, but will try to respond in as vendor-neutral a way as I can. You should complete an IQ/OQ of your SAS...
David Smith
David.Smith@...
Jun 3, 2004 3:09 pm
11646
Hi Kim, I don't know what version of SAS you are on but the SAS 9 qualification tools have been backported to 8.2 and are available here: ...
Paul, First I'd like to thank you and Chris and Kate for your replies to my question. I really appreciate it. I've found the GAMP 4 guide from ISPE and is...
Kim, You've gotten a lot of good info already (although some parts conflict with other parts). My two cents: We qualified the installation of SAS. Different...
Hi, Currently I am studying the compliance implications of the Sarbanes- Oxley Act on the pharmaceutical industry, especially on the Information Services...
If anyone hears what will happen with the June 11 meeting on Part 11, please post ASAP. The federal government is to be shut down on June 11 for President...
Hi Sankar, you will find general information under www.isaca.org (look for IT controls) The question that we are faced in the moment by our customers is: How...
Hello Sanker, This may help. I have also been involved in this project and whilst not deemed GMP critical the act has far reaching consequences. Hope this...
Cancelled with no reschedule! Here is the announcement: As most of you have heard, Federal agencies will be closed Friday, June 11th as part of the national...
Hi Chris, Thanks for the information. This site has some interesting articles. Sankar ... controls) ... be ... yearly) ... material ... European point of view...
Hi Paul, Thanks for your response. I completely agree with you that this act has far reaching consequences. By the way, did you intend to send me a link? I...
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