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IQ/OQ/PQ of Equipment after a PC change
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IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
IQ/OQ/PQ of Equipment after a PC change
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IQ/OQ/PQ of Equipment after a PC change


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  Post Number #1  
Old 17th May 2018, 06:35 PM
My QA 2018

 
 
Total Posts: 2
Please Help! IQ/OQ/PQ of Equipment after a PC change

We recently had to replace the PC on a previously qualified (IQ/OQ/PQ'd) BioRad CFX96 instrument in our Lab. We are ISO 13485 Certified company that does R&D and Product Development.

My recommendation was to minimally document the details of the replacement PC and the installation of the CFX application Manager Software in Memo form and to perform a PQ. The QA/RC Management Representative does not believe either the memo or re validation is necessary/required.

I am not convinced!

Is there anyone here that could help me understand.


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  Post Number #2  
Old 18th May 2018, 02:27 AM
John Rickey

 
 
Total Posts: 2
Re: IQ/OQ/PQ of Equipment after a PC change

If the connection between the instrument and the data line is strictly a data connection, I would tend to agree that the memo and re-validation are not required. I would still do the memo for future reference (and for the next person who needs to replace the computer); it does not need to filed as a quality record.

However, if the instrument includes a card that goes in the computer, then definitely have the memo and re-validation as part of quality records. The different cpu or bus speed of the new computer could easily change the measurements.
Thank You to John Rickey for your informative Post and/or Attachment!
  Post Number #3  
Old 18th May 2018, 08:05 AM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,679
Re: IQ/OQ/PQ of Equipment after a PC change

Did it pass through your change management process - that process and the initial validation protocols should specify when and at what level requalification is required.

either way I would think this is minimal if you reinstalled the same software and files. I would do a check to ensure data integrity - audit some old records to make sure nothing was lost in transfer, etc.

So I guess I'm on the "do something" side.

If you have a change management process then that should capture the information and memo may not be needed.
Thank You to ScottK for your informative Post and/or Attachment!
  Post Number #4  
Old 18th May 2018, 11:47 AM
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BradM

 
 
Total Posts: 6,002
Re: IQ/OQ/PQ of Equipment after a PC change

First, regardless of whether you "have to" or not, it's always a good idea to document things.

What level of "change" this replacement represents is how the system works together and how it was qualified. If the PC is highly integrated with the equipment, I believe some rudimentary check is in order to assure it's a like for like change, and that the new PC will not introduce unwanted variables.

If it was my system, I would want some (albeit abbreviated) PQ test to assure the system still operates as intended.

It doesn't hurt to take a little more time to test it does what it should.
Thanks to BradM for your informative Post and/or Attachment!
  Post Number #5  
Old 18th May 2018, 12:11 PM
My QA 2018

 
 
Total Posts: 2
Re: IQ/OQ/PQ of Equipment after a PC change

Quote:
In Reply to Parent Post by ScottK View Post

Did it pass through your change management process - that process and the initial validation protocols should specify when and at what level requalification is required.

either way I would think this is minimal if you reinstalled the same software and files. I would do a check to ensure data integrity - audit some old records to make sure nothing was lost in transfer, etc.

So I guess I'm on the "do something" side.

If you have a change management process then that should capture the information and memo may not be needed.
Scott K,

Thank you for your response. I tend to always "do something" too.
It is not highly integrated as far as I understand since I am not the user.
We did not have Change Control. We just used a New Equipment Acceptance Form and an Equipment Decommission/ Transition Form. A few email communications with IT and the manufacturer on the computer requirements and steps on installing the Application software.

Last edited by My QA 2018; 18th May 2018 at 12:18 PM.
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