All, Getting my hands dirty with spreadsheet validation and need some advice. One of our first steps was to take a look at how many spreadsheets we actually...
Dear All, I'm interested about the standard GCP for Clinical trial that involves collecting DNA and genetic epidemiology data from patients. If you please...
I need some serious input or argument points to prove this in a presentation. THis company doesn't have any audit trails in place, has not alloted for the...
A clinical trial protocol for a medical device's PMA has been submitted to the FDA and approved. During the course of the clinical trial, the protocol is...
Hi Ian Make a positive list. What it means is. Ask the User to tell you witch Excel Spreadsheet is GxP relevant. Therefore you generate a list with yes / no...
I woul dhave to take one step back and ask what is the software tool going to do first. If it is making decisions on product safety, potency, purity and/or ...
Skaternum, I agree with Jennifer on this, after all it is those records your proof that you are actually following your SOP's. For example, you might have a...
... Ian, Most searching and filtering technologies depend on the association of certain keywords and/or metadata to the items being searched. Sometimes the...
You do not need to assess each one individually. What you should do it sit down with each department and ask which spreadheets they use to make GxP decisions...
Seaselkys, I do not know how the other guys feel, but I think you have included too little information for anyone of us to do an educated point. Including a...
Ian, It is quite a task, especially with that number. However, it is not uncommon to find a startling number of spreadsheets out there. ABB has experience...
You filter by asking the owner questions - which documents do you use for gxp purposes. Just because a spreadsheet has not been modified does not mean it is...
Hi Orlando, More usually, the Signatures that are legally binding in a computer system are referred to as Electronic Signatures, Digital Signatures are usually...
Sajidpjos, I’ve seen a company purchase software, more than once, and then have the purchaser racked over the coals because the vendor did not follow IEEE...
Hi colleagues I'm responsible in a project for the compliance of a archiving system. Regarding to many posted threads about acceptance of scanned "true" or...
I am in the Frederick, DC area as well... Jennifer ... _________________________________________________________________ Don’t just search. Find. Check out...
... Good morning, Chris. I am based in New Hampshire but am currently working in Huntsville, AL. I might be able to make it up if it is no farther north than...
Ravi, while I can’t provide you copies of proprietary protocols for SAP’s PP and SD modules, I can provide you with the following suggestions on how to...
You really should not need specific training from a QA perspective or a validation perspective. A little training from a validation perspective may be nice in...
Hi William thanks a lot for the info and for your time in answering my question ravi ... modules, ... are ... protocol ... security, ... audit ... Thanks and...
Ravi, The people that can help you with the sample scripts are within your company. They are the ones that will take over the system once it’s set up. Script...
Thanks a lot ravi ... Thanks and Regards Ravi 973 280 8268 ravimami@... __________________________________ Start your day with Yahoo! - Make it your home...
Hi there Apologies if this is a frequently asked question, but am new to the 21-CFR-11 standard so probably prone to asking the obvious... I'm working on some...
Dear members, I would like to get your opinion on the scope and purpose of exploratory tests. Typically my view is that exploratory test can be used if want to...
It seems like what you're describing is testing in a development environment? I don't see any harm in that, as long as you outline your rationale up front....
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