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  #1  
Old 19th January 2004, 09:12 AM
Fatboy Fatboy is offline
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Please Help! Software Control
Does anyone have a procedure for software validation/control that you are willing to share for benchmarking? I am trying to rewrite our old procedure and was wondering what others are doing in this area. Our current procedure requires quite a bit of work as it was designed with our nuclear department in mind. However, it may be a little too comprehesive for our industrial divisions.

We have software that is written for product testing, software that is used for programming transmitters (written by others), and business software (Word, Excel, Autocad, etc.).

Thanks in advance.
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Old 19th January 2004, 09:30 AM
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Default Re: Software Control
Hello Fatboy,

I have experience with SW validation in the pharmaceutical (FDA, EU GMP) environment, and now I am working on the requirements for SW validation for medical devices.

I also did some ITIL work on (IT)service delivery and support (which is a different approach to this topic).

Yes, I am interested in exchange
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Old 19th January 2004, 09:46 AM
Fatboy Fatboy is offline
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Default Re: Software Control
Attached is a copy of our current procedure. As stated before, I believe that it is a little too restricting.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting the post it is in, 3. Use at your Own Risk.
File Type: pdf Reg. 100-20.1 Rev. 1 (Software Quality Assurance).pdf (417.8 KB, 393 views)
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Old 21st January 2004, 11:56 AM
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Default Re: Software Control
Hi folks,

I have been battling this same topic for a while now....there are so many standards out there for software control and SQA...I am currently trying to focus on the Engineering life cycle and the SW Development life cycle and use the checks and reviews that make sense for our organization/product...it is not an easy thing to digest though!The Capability Maturity Model is useful as well....

I would like to share some info on this too, but I am not able to read attachments yet...and the actual procedures we have are quite ad hoc right now

Cheers!
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Old 18th September 2006, 01:07 PM
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Default Re: Procedure for Software Validation and Control
This guide may be useful.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting the post it is in, 3. Use at your Own Risk.
File Type: pdf fda software validation guidance.pdf (161.8 KB, 244 views)
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