Currently we have 339 forms, and we do not have any completed examples of those forms.

FACT requires us to have completed examples of forms.

For thoses of you trying to meet this requirement, do you have completed examples of all of your forms, or only those related to FACT activities?

What is FACT? (may be a stupid question but to me no question is a stupid question!!!!)

I agree, there is no such thing as a stupid question.

FACT = Foundation for the Accreditation of Cellular Therapy.

http://www.factwebsite.org/Home_Page.htm

I was in the same situation. I include completed examples of the forms that FACT is concerned about in my HPC (human progenitor cell) manual. So far, no other agency has required this.

Cliff,

We also are FACT accredited and our program decided that all forms about 400(FACT regulated and non-FACT regulated) need to have samples in the SOP manual. Prior to our last FACT inspection we had staff members go through the SOP manuals and make samples using directions in the SOP. This was a great training tool and good way to validate the SOP. So we added "make sample form" to our validation checklist. This prompts someone to make the sample. Training and validation all in one! Yeah! Yes it is tedious but it works for us.

Hope this helps.

Carrie Cox

Our facility is FACT accredited and just for consistency, we have completed forms for both HPC processing and for our flow cytometry department.

As mentioned above, a great learning tool, and also some feedback as to what changes might improve the forms.