# Audit checklist for the U.S. Food and Drug Administration (FDA)'s Guidance
# document "Guidance for the Content of Premarket Submissions for Software
# Contained in Medical Devices"
# Based on version 2005-05-11
#
# 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.
#
FDA-CPSSCMD:level-of-concern A statement indicating the Level of Concern and rationale for that level
FDA-CPSSCMD:software-description A summary overview of the features and software operating environment
FDA-CPSSCMD:device-hazard-analysis Tabular description of identified hardware and software hazards
FDA-CPSSCMD:srs Software requirements specification
FDA-CPSSCMD:architecture-design-chart Detailed depiction of functional units and software modules
FDA-CPSSCMD:sds Software design specification document
FDA-CPSSCMD:traceability-analysis Traceability analysis
FDA-CPSSCMD:dev-environment The software development environment description
FDA-CPSSCMD:v-and-v Verification and validation documentation
FDA-CPSSCMD:revision-history Revision history log, including release version number and date
FDA-CPSSCMD:unresolved-anomalies List of remaining software anomalies
# TODO: add more granular requirements to this list
