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

K

kisna

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.
 

yodon

Leader
Super Moderator
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

+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

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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