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Computer System Validation


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#1 JamieLynn

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Posted 03 April 2018 - 03:06 PM

I'm looking for some help with starting a Computer System Validation SOP!!!  I was scheduled for a class but it was cancelled (and not available again until June).  Any help would be greatly appreciated- I don't even know where to start  :dunno:



#2 Ansh3

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Posted 04 April 2018 - 05:07 AM

Computer System Validation SOP 

 

Hi Jamie,

 

You need to put in more details of what you are looking for , is it software , hardware. Is this for a production audit or IT audit.

 

The SOP will differ for each topic. Also , the depth required will be different for each. 

 

You say that you were scheduled for a course...Do you have outline/topics for the course? If yes, then share the topics and forum can help you better.

 

From a HSE risk analysis perspective for office environment , I did a risk analysis some years back. Attaching the same. Whether you need it or not , will depend on what you need SOP for. 

 

Hope it helps.

 

Attached Files



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#3 JamieLynn

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Posted 09 April 2018 - 08:20 PM

I'm looking for assistance specifically with meeting the data integrity/computer system validation requirements under FSMA/FDA.  The course discussion topics are:

  • The regulatory expectations for computer validation
  • Relevant FDA warning letters
  • The tasks and deliverables expected for computer validation
  • Why validation processes vary so much
  • Strategies for practical, yet defensible computer validation
  • Sops required for system operation and maintenance
  • 21 CFR part 11 and it's implications for common regulations
  • An active discussion of part 11 examples and audience questions
  • The implications of GAMP 5 on computer validation and how to transition from GAMP 4
  • Auditing GXP computer systems and suppliers





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