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  Controlling software

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Author Topic:   Controlling software
Dawn
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Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 11 December 1999 10:18 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
I have been told by the auditor that if we have information maintained in computers how is it controlled? We have work instructions for backing up the computers. Do we need anything else? (Lost)

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Roger Eastin
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From:Greenville, SC
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posted 13 December 1999 03:18 PM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
Are your electronic information, records or documents (level 3)? You probably need to supply some more details as to what kind of information you are talking about. If it is level 3 information, then standard control procedures must be followed per Element 4.5. However, if the information is records then it must follow your procedure for quality records. The type of media that you use, whether paper or electronic, has to follow your standard procedures. Now, if you are talking about software that is used in some sort of process (NC machines, maintaining quaity records with some sort of database, etc.), then you, as you have stated, have to provide a system for backing up this software on a regular basis.

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Marc Smith
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From:West Chester, OH, USA
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posted 13 December 1999 04:49 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Now, if you are talking about software that is used in somesort of process (NC machines, maintaining quaity records with some sort of database, etc.
How about Change History?

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Roger Eastin
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posted 14 December 1999 10:41 AM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
Are you referring to the Change History of the software itself or of the data that the software uses? Most times the change history of the former case is maintained by the folks who wrote the software and I suppose that access to that history may be needed, for instance, to determine if a company needs to upgrade that software. If you mean the latter case, then I agree that a change history is needed (per 4.5) by the company inputting the data.

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Marc Smith
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From:West Chester, OH, USA
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posted 14 December 1999 10:55 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Change history of the software - not the data.

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