GE ReadyToProcess WAVE 25 Operating Instructions Manual page 14

1 Introduction
1.3 Regulatory information
1.3.4 Other regulations and standards
Software declaration of
conformity
UNICORN 6.3, 7.0 and later versions are technically compatible with all relevant sections
of FDA 21 CFR Part 11.
A part 11-system assessment checklist is available on request from your local GE repre-
sentative.
14 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD