# Audit checklist for the U.S. Food and Drug Administration (FDA)'s Guidance
# document "Content of Premarket Submissions for Software Device Software
# Functions" for devices requireing the "Enhanced" Documentation Level
# Based on the draft version, published on 2021-11-04.
#
# This checklist is not a substitute for reading, understanding, and
# implementing the associated guidance document, which can be found online for
# free on https://www.fda.gov. The descriptive phrase following each keyword
# reference is intended only as a helpful mnemonic for locating
# and recalling the referenced section of the standard.
#
include FDA-SW_2021_basic
FDA-SW:sds Software design specification document

FDA-SW:sdmp-config-full A complete configuration management plan, in addition to the summary for the basic level
FDA-SW:sdmp-maintenance-full A complete maintenance plan, in addition to the summary for the basic level

# TODO: once rdm gaps supports implied completions, then uncomment these items
# FDA-SW:sdmp-maintenance-full --> FDA-SW:sdmp-maintenance
# FDA-SW:sdmp-config-full --> FDA-SW:sdmp-config

FDA-SW:vandv-unit-protocol Unit level testing protocol
FDA-SW:vandv-unit-report Unit level testing report
FDA-SW:vandv-integration-protocol Integration level testing protocol
FDA-SW:vandv-integration-report Integration level testing report