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...
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...
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,...
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...
... + 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...
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 ...
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....
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...
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...
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 ...
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...
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...
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:...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Apr 4, 2005 1:23 pm
13522
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...
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...
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...
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. ...
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...
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...
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...
It should be validated to ensure that the data transfer is accurate and complete. ... From: madhavi25 <madhavi25@...> To: 21cfrpart11@yahoogroups.com ...
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. ...
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...
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...
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