Derek, Thank you for the info. I will check the Ofni website to track Ty down for more info. Dignah...
13506
Juan O. Perez
qcsvpr
Apr 1, 2005 6:30 pm
When I was in IT, it was that way, we were the administrators, but we did not have to be trained in how to use the system as a lab technician, but we did...
13507
Juan O. Perez
qcsvpr
Apr 1, 2005 6:30 pm
Hey Jerry You are right I meant 11.10(i), thanks for the correction. Regarding the gray area, I don't think is that gray. As you mentioned in your other...
13508
tbnelson777
Apr 1, 2005 6:31 pm
I'm new to the group and appreciate all of information that is shared. I'm learning a lot. I work for a software company that produces bar coding software,...
13509
john leonard
john_leonard...
Apr 1, 2005 6:31 pm
If someone can delete data, and if there is the slightest possibility that data is relevant and required for a submission or relevant to a manufacturing...
13510
Chris Whalley
chriswhalley
Apr 1, 2005 9:54 pm
... + Agreed, but, for someone to "know what they are doing" they only have to understand what data is in the files, not how to use the software that acquires...
13511
wjgates2002
Apr 1, 2005 9:54 pm
Yes, it does. You use the SUIM transaction to display the audit trail. ... be to ... when ... same as the ... know ... if...
13512
wjgates2002
Apr 1, 2005 9:54 pm
Yes, it does. You use the SUIM transaction to display the audit trail. ... be to ... when ... same as the ... know ... if...
13513
Kathryn Manchester
buggsy401
Apr 1, 2005 9:54 pm
Exactly. We do the same with our administrator accounts so we can track who is doing what. Kathie ... From: "Juan O. Perez" <qcsvpr@...> Reply-To:...
13514
Jay Finnigan
jfinniganpart11
Apr 1, 2005 9:55 pm
Does anyone know of a good Forms software package for a small to mid size company? Can't be too expensive. Thanks, Jay Finnigan Vice President, Operations ...
13515
Jay Finnigan
jfinniganpart11
Apr 1, 2005 9:56 pm
Folks, Sorry about not being more specific on my request for a good Forms Software Package. What I'm really searching for is "control" not creation of forms....
13516
john leonard
john_leonard...
Apr 1, 2005 9:56 pm
Tom, If I were auditing your facility, I would also expect to see a "Validation Plan" which described each of the activities below; who had responsibility for...
13517
Greg Ventura
gwventura
Apr 4, 2005 1:21 pm
I just have to chime in on Escrow of source code. We have decided that we are going to drop our SOP on how we handle this. We will still offer to escrow source...
13518
Snehal Pandya
snehaldpandya
Apr 4, 2005 1:23 pm
Yes indeed. You can test this assumption by creating a user-id which was deleted. System tries to populate as much information as is available in the database ...
13519
kevin_r_luck
Apr 4, 2005 1:23 pm
We produce an integrated building access control and alarms management system and have been asked by one of our clients to provide a statement regarding our...
13520
dwimmer2002
Apr 4, 2005 1:23 pm
Jay, Do you want to create the forms within the software, or are they existing forms created in another software? Are these forms to be filled out on paper, or...
13521
Schmitt, Siegfried (G...
siegfried.schmitt@...
Apr 4, 2005 1:23 pm
Have a look at Adobe Acrobat Professional version 7.0 - you only need one or two licences, all others can work with the free reader Regards Siegfried ... From:...
13522
john leonard
john_leonard...
Apr 5, 2005 5:27 pm
Kevin, Your client has to prove that his data is safe and reliable. It order to facilitate that he would probably want a system with built in logs, different...
13523
jeffyearley
Apr 5, 2005 5:27 pm
A system produces data files that are said to comply with a current XML format standard. What is the best and most efficient way to validate the output files...
13524
madhavi25
Apr 5, 2005 5:28 pm
Our In house built system transfers GxP data from One GxP system to the other GxP system ..it does not store any data , it just transfers …. Did anybody...
13525
mt_ski
Apr 5, 2005 5:40 pm
Absolutely. Is this a data migration? Mark Taras www.ProcessAnalyticalTechnology.com ... the ... …....
13526
Snehal Pandya
snehaldpandya
Apr 5, 2005 5:41 pm
Yes ofcourse, The system which receives this data has to have as part of Input validation because it is not being entered but being received thro a software. ...
13527
Chris Whalley
chriswhalley
Apr 5, 2005 7:40 pm
If you're using XML to prepare a regulatory submission in eCTD format, here's a good resource to start with, http://www.ectd.com/index.htm The ability...
13528
Greg Ventura
gwventura
Apr 5, 2005 7:41 pm
Open the XML file and try to do something with the data. Verify that the number of records is correct. We did some testing for CDISC where we checked that the...
13529
anamika
sapna_79
Apr 5, 2005 7:41 pm
Hi All, Would appreciate any ideas/views on validating our PK software Nonmem/pdxpop? How far should we be going to get it validated. Would really like input...
13530
dra369@...
krownedqueen
Apr 5, 2005 7:41 pm
It should be validated to ensure that the data transfer is accurate and complete. ... From: madhavi25 <madhavi25@...> To: 21cfrpart11@yahoogroups.com ...
13531
Juan O. Perez
qcsvpr
Apr 5, 2005 7:41 pm
Validation will help you ensure that data transfer is reliable and data of receiving GxP system has not been altered in anyway during the transfer process. ...
13532
akasharya@...
akasharya74
Apr 5, 2005 7:41 pm
Agreed, you should also verify the that data isn't corrupted or manipulated in any way as it goes from location to location. Is there a bottleneck in the...
13533
Alexander Witzigmann
jungo92000
Apr 5, 2005 7:42 pm
validate xml data can be divided into * well formed check this is the minimal requirement all xml instances must conform to ...
13534
jhduckw
Apr 5, 2005 11:22 pm
If the schema or DTD is for a public domain format (like eCTD) or available from the creator (vendor?) of the system, you can use a commercial XML authoring...
