LIMPER55 Posted September 25, 2011 Share Posted September 25, 2011 We are a small transfusion service. We have tested the ISBT products and have written the basic SOP'sI am trying to write a validation plan.Does anyone have a site or template they would like to share?The last inspector mentioned fda.gov has a template?thanks for your help. Link to comment Share on other sites More sharing options...
David Saikin Posted September 26, 2011 Share Posted September 26, 2011 I have attached my validation template . . . good luck. It is generic. Link to comment Share on other sites More sharing options...
Deb Posted September 26, 2011 Share Posted September 26, 2011 I've attached 3 documents that we used when we implemented ISBT. You may or may not find them helpful.1. Label Validation Master Form: We verified all of the fields of a label were in the correct position, indicated the correct wording, etc.2. The Label Sample page was how we compiled our Master Label Sets.3. Label validation Scan Page allowed us to scan related labels in to verify they scanned correctly.[ATTACH]534[/ATTACH][ATTACH]535[/ATTACH][ATTACH]536[/ATTACH] Link to comment Share on other sites More sharing options...
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