Saludos a todos, A recent ruling from the FDA's CDRH and my interpretation of the implication of such ruling.... The following is from the FDAnews Device Daily...
Spreadsheets used to generate or manipulate predicate data - must be validated. Just search through the warning letters and you will find hundreds of examples....
Saludos Alex, Your statement "Excel cannot be validated" is too strong.. You do not take into account the intended use and third parties "build-ins". The...
Another issue is that it is difficult to truly meet the issue of security to users. I think that if you can find an alternative it would save you a lot of...
Saludos Jeremy, I'm not sure that security is an issue. For example configuration management to the spreadsheet application can be established. You can...
Wimmer Systems offers a Data Compliance System (DCS) that is claimed to make Excel spreadsheets compliant with 21CFR Part11. DCS provides an Add-in that...
CDRH just wants an e-copy to make it easier for distribution to consulting reviewers. The site below has an explanation of what they would really like to see...
DaCs, the add-on that makes Excel compatible with a Part 11-compliant environment, was purchased by Compassoft from Wimmer. Compassoft just went out of...
Margaret: I, too, remember Derek's system (DACs)to be very worthwhile. But, as I recall, his company was sold or taken over by Compassoft. I'm not sure...
Good day Patricia No one is decrying Excel, we use it extensively for many tasks. However there are problems both with documentation and processing in Excel,...
Hi all, "If excel is used to manipulate predicate data, especially when that data is used as a decision maker, the software gets classified as critical...
Hi A good point of reference for development and validation of spreadsheets is the FDA themselves. Like most laboratories they use spreadsheets in their own...
Hello, Has anyone had experience with this situation: A clinician scans a patient at a clinic and sends a file to an orthosis manufacturer at a remote location...
Yes the software has to be validated. This was already answered by the FDA. Check July 14 WL to Schroeder Industries, Inc . In a subject not related...
A quick question for the group, part of a spirited discussion I am having… Does FDA Part 11 require OR recommend that an electronic system be capable of...
I would suggest reading the regulation. I would also suggest reading the preamble to the regulation. § 11.300 Controls for identification codes/passwords. (b)...
You might want to do a search of the archives because this topic has been beaten to death in here.... Greg ... -- Greg Mendizabal gmendi@... [Non-text...
DaCS is marketed today by ABB in partnership with Compassoft: http://www.abb.us/service/seitp335/c1256ccb004e87aa80256ce500476f38.aspx?tabKey=7 I vaguely...
Hi Last year a mini-series of articles regarding validating Excel applications was published in the Pharma IT Journal (www.pharmait.co.uk). These articles...
Hello everybody, I need to know the proper methodology related to URS. Are these the steps to follow with the URS? Is correct: 1-The user sends an e-mail...
In my humble opinion, whether or not a particular software application will be validated is not relevent to producing a good URS. As you did not mention which...
I think it just makes good business sense to always have a URS. Without an URS, how do you know that you have satisfied your user's needs? Greg Ventura ... ...
Saludos Carlos, You may want to start with the enclosed link. http://en.wikipedia.org/wiki/User_requirements_document The user requirements, best called the...
jjacksonagile, The rule says: § 11.300 Controls for identification codes/ passwords. Persons who use electronic signatures based upon use of identification...
I agree 100%. The user requirements are also used as a source in documenting the GxP impact assessment. ... [Non-text portions of this message have been...
Dear Carlos The requirement document plays a key role for good engineering&software practices and principles. IEEE have defined standards for requirements...
Dear Sir, My question is about the contents of the Software validation protocols in general, We have a software validation master plan that refers to the...
Hi; Does anyone can guide me how can I perform interference testing for wireless system? thanks [Non-text portions of this message have been removed]...
Saludos Ali, Try http://www.ibm.com/Search/?sn=1&q=wireless+and+testing&v=16&lang=en&cc=us&en=utf&Search=Search or Chapter 17 in “Computer Infrastructure...
To make my replay short...Assuming that you will be using a software package, the testing in the qualify the application is based on the intended use,...
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