Hello everyone.  We are going to start doing ABO titers at our facility and I have been asked to prepare the validation plan for this new procedure.  The problem is that I have NEVER written a validation plan.  What information do I need to include in the plan?  Does anyone have a template for a new procedure validation plan, and willing to share??? 

I've attached my process validation plan.  Let me know if you need more info.

Process Validation Template.doc

Here's the one our entire lab uses.

Validation Plan and Results Review.docm

David and Carrie, thank you SO much for your help.  I really appreciate it!

Both of these are good examples.

We do our validation in three parts:  Installation Qualification, Operational Qualification, and Production Qualification.

The IQ just shows how it was installed.  For a piece of equipment it could be the installation checklist.  For a test it could be screen shots of whatever was changed in the computer to create the test.

Operational Qualification shows that a piece of equipment does what the manufacturer says it will do.  What I do for a test is build it in my Validation Environment and test it there.  If that passes, I build it in the Production Environment and test it again.  I can't move a computer build from one environment to another.  So the testing method for OQ and PQ for a test is usually the same.

However you validate, be sure to get your Medical Director to sign off on it.

Thank you so much for replying Baby Banker.  I appreciate it.

https://www.b-s-h.org.uk/guidelines/guidelines/validation-and-qualification-including-change-control-for-hospital-transfusion-laboratories/

This document has templates at the back and risk assessment info too

Allard_et_al-2012-Transfusion_Medicine_Validation_guidelines.pdf