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
1 Introduction
1.3 Regulatory information
1.3.4 Other regulations and standards
