Healthcare Software

What Does the FDA Check when it Audits your Source Code?

Code compilation

• Make sure that the strictest options for error checking are used.
• Verify the existence and correctness of the documentation of the compilation process.
• The absence of warnings or other alerting messages during the compile.

Coding guidelines

• Check for a document specifying your coding guidelines.
• The guidelines should provide details about clarity, style, complexity management and commenting.
• The code is checked to make sure it adheres to the coding guidelines.

Comments

• Comments need to be useful and descriptive for a module, should list the expected inputs and outputs, variables referenced, expected data types and operations performed.

Design specification

• Check that the source code agrees with the specified detailed design specification.
• Check that everything in the detailed design specification is in reflected in the code.
• Modules should be documented for their compliance to coding standards and other stated quality policies and procedures.

Test cases

• Check that the tests for modules and functions can be traced to the code for the same modules and functions.
• Test cases for modules and functions can be traced to the correct modules and functions in the detailed design specification.
• Verify test coverage for modules, integration, system and acceptance.

Process documentation

• Documentation for procedures used and the results of the source code evaluation should be maintained as part of design verification.