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Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
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Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
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Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template


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Some Related Topic Tags
computers, forms and templates (general), gamp (good automated manufacturing practice), gamp validation procedures, installation qualification (iq), operational qualification (oq), performance qualification (pq), validation master plan (vmp), validation plan
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  Post Number #1  
Old 9th October 2017, 01:04 PM
kisna

 
 
Total Posts: 1
Thank You! Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template

Hi Everyone,

I recently joined a pharma company. I have strictly worked in IT Field and this is my first time working in pharma side of IT field. I found Elsmar when I was searching online. Hopefully, i will be able to find the answers from all of you.

So i have been told to create a "Computerized System Master Validation Plan that involves IQ-OQ-PQ for LAB system which includes mainly hardware (Servers and workstations) and minor softwares (installation Qualification and anything of importance). I have never done this before, can anyone provide me with some draft or a template of a sort where I can easily add the information required?

Is there anything else that i should keep in mind for future? Any information shared will be gracefully appreciated.

Thnak You Very Much in Advance.

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  Post Number #2  
Old 9th October 2017, 02:09 PM
yodon

 
 
Total Posts: 1,121
Re: Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template

You might want to start by getting the GAMP 5 manual. They lay out all the aspects of a good validation system and is targeted for the pharma community.

Note that they don't, however, GAMP 5 doesn't exactly endorse the IQ-OQ-PQ paradigm (they do provide a mapping between those activities and what they do endorse).
  Post Number #3  
Old 10th October 2017, 09:47 AM
locutus

 
 
Total Posts: 43
Re: Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template

+1 to yodon, GAMP 5 is the fairly de facto Computer System Validation (CSV) methodology that is used in pharma (and can be applied to med device as well).
  Post Number #4  
Old 10th October 2017, 10:02 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Re: Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template

Wikipedia reference-linkGood_automated_manufacturing_practice
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