Kelley:

There is a lot of documentation involved (i.e., "traceability"), a lot
of regimentation, and a lot of regulations.  Without going into detail,
which would take awhile, a good reference to details can be found at
www.glpguru.com.

Peter

--
Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
STEREOTAXIS, Inc.
Direct phone 1-314-615-6964
FAX 1-314-615-6912
Pager 1-314-841-9351
ptakes@stereotaxis.com