# 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 "Basic" 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.
#
FDA-SW:dle A statement indicating the appropriate Documentation Level and rationale for that level

FDA-SW:sd A summary overview of the features and software operating environment
FDA-SW:sd-other Other software device functions

FDA-SW:ssad Detailed diagrams of modules, layers, and interfaces that comprise the device

FDA-SW:rmf-plan An ISO-14971-compliant plan that defines how the risk acceptability criteria
FDA-SW:rmf-assessment A risk assessment table demonstrating that risks have been appropriately mitigated
FDA-SW:rmf-report A risk management report that demonstrates how the plan was implemented

FDA-SW:srs Software requirements specification
FDA-SW:srs-tracking A description of the software requirement identification and tracking methodology

FDA-SW:sdmp The software development and maintenance practices document

FDA-SW:sdmp-dev-processes Processes and procedures used in software development
FDA-SW:sdmp-vandv Processes and procedures used in verification and validation.
FDA-SW:sdmp-cmt Standards (e.g., coding), methods and tools used in software development
FDA-SW:sdmp-outputs Main deliverables of the typical software development and v-and-v activities
FDA-SW:sdmp-traceability Processes, procedures, and tools used to handle traceability
FDA-SW:sdmp-config Processes and procedures used in software configuration and change management
FDA-SW:sdmp-maintenance Processes and procedures used in software maintenance

FDA-SW:vandv Verification and validation documentation
FDA-SW:vandv-summary Summary of the unit, integration, and system-level testing
FDA-SW:vandv-changes Description and justification of changes made in respond to failed tests
FDA-SW:vandv-regression-analysis Analysis of unintended effects of fixes
FDA-SW:vandv-system-protocol System level testing protocol
FDA-SW:vandv-system-report System level testing report

FDA-SW:rlh Revision history log, including release version number and date
FDA-SW:ua List of remaining software anomalies