SPSS Functional Validation Documentation

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gvalbusa
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SPSS Functional Validation Documentation

Postby gvalbusa » Thu Jan 31, 2008 9:47 am

Hi,

I'm looking for the functional validation documentation of SPSS (I need it for a specific request from a regulatory agency). I mean the documents containing the lists of all the tests done to demonstrate the exactness of SPSS's calculation.

Do anybody knows where I could find these documents?

Thanks
statman
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Postby statman » Thu Jan 31, 2008 1:41 pm

This could be the set of algorithm papers available at www.spss.com

Link to

Code: Select all

http://support.spss.com/tech/default.asp
for information or better still, they should be on your install CD

What version of SPSS is being referenced since there have been changes?
See the note below

NOTE: Please read the Posting Guidelines and always tell us your OS, the SPSS version and information about your study and data!

Statman
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gvalbusa
Posts: 5
Joined: Thu Jan 31, 2008 9:36 am

Postby gvalbusa » Thu Jan 31, 2008 1:50 pm

I can't enter that page, I have not a support contract with SPSS maybe.

Anyway what I am looking for is a technical report about validation procedures performend to test SPSS functionality.

I'm managing the transition between another statistical software to SPSS and the chief of the laboratory need the 'validation documentation'.

I think it should be the list of the functional testing performed to test the SPSS functionalities (calculation correctness, exceptions handling and so on).

I can't find it on the website, but I think it surely exists, maybe is not accessible directly through the web site.

Thank You
statman
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Postby statman » Thu Jan 31, 2008 7:21 pm

Don't know if they can help but email SPSS stat support site at

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statsupport@spss.com
gvalbusa
Posts: 5
Joined: Thu Jan 31, 2008 9:36 am

Postby gvalbusa » Fri Feb 01, 2008 9:49 am

Thanks I'll try!
gvalbusa
Posts: 5
Joined: Thu Jan 31, 2008 9:36 am

SPSS meets the FDA CFR 21 part 11 requirements?

Postby gvalbusa » Mon Feb 04, 2008 2:57 pm

Dear all,

I have now a more precise request?.

Is there a document which shows that SPSS meets the FDA CFR 21 part 11 requirements?

This is an excerpt from a FDA document about the scope of application of CFR 21 part 11:

"Part 11 applies to records in electronic form that are created,26 modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules."

Does anybody have an answer to this question?

Thank you
statman
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Postby statman » Mon Feb 04, 2008 9:52 pm

On this, you might contact SPSS directly via phone and get directed appropriately
gvalbusa
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Postby gvalbusa » Tue Feb 05, 2008 8:46 am

I will!

Thank you!
statman
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Joined: Tue Jun 12, 2007 12:08 pm
Location: Florida, USA

Postby statman » Fri Feb 22, 2008 8:46 pm

How did this go?
See the note below

NOTE: Please read the Posting Guidelines and always tell us your OS, the SPSS version and information about your study and data!

Statman
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