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HELP--ABO titer validation plan

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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??? 

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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.

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