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

K

kisna

#1
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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yodon

Staff member
Super Moderator
#2
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).
 
L

locutus

#3
+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).
 
A

Alex Kennedy

#5
Be careful with GAMP documents 2 to 5. They were written by committees and as such; try to write simple solutions, that fit all purposes. So, you will find contradictions in their methodologies.

However, GAMP can be a useful document when you are tasked with writing your Company's Software Practices & Procedure SOP or manual, then you can research through it and extract the tasks and information most appropriate for your requirements.
 
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