White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide - Chapter 10: Starters
Key Points: Documenting the Receipt and Delivery of Starters
Document all starter transactions completely and accurately at the time they occur.
Utilize the iCUE tablet to document all starter transactions (unless one of the limited
exceptions permitting paper SAFs described in this Chapter apply).
Provide complete, accurate and truthful information on all eSAFs (and paper SAFs, in the very
limited circumstances when a paper SAF is permitted).
Witness the receiving HCP sign the iCUE screen (or paper SAF) at the time of delivery.
Immediately report any and all shipment shortages or overages, starter losses, and thefts to
Starter Operations for further evaluation and reporting to the FDA.
Completion of eSAFs and SAFs
Sales Colleagues using an iCUE tablet must utilize the tablet for every starter transaction – subject to
two very limited exceptions outlined below. A paper Starter Activity Form (SAF) may only be used:
When a Sales Colleague is dropping starters at an institution that requires the starters be left
with its pharmacy and not with the individual HCPs requesting them (in this case, the dual-
signature “In House Pharmacy” SAF described in this Chapter must be used), or
With prior written approval from Starter Operations in very limited, infrequent
circumstances while the iCUE system is inoperable due to significant hardware or software
malfunctions for an extended period of time, until such time as the underlying causes of the
malfunction are resolved. (Sales Colleagues should ensure that their iCUE tablets are
charged; drained batteries do not qualify as an iCUE malfunction.) Written requests may
only be submitted by Sales Colleagues by e-mailing a description of the issue, and
information provided as part of the CSC Help Center assigned ticket, to
StarterCompliance@pfizer.com.
If a paper SAF is utilized as permitted above, Sales Colleagues must enter the information into iCUE as
soon as possible after completing the paper SAF transaction.
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