Project Description:

Our Client engaged a third party to duplicate a Digital Gauge attached to an oxygen tank used for patient care. The new Gauge was to be lighter weight (plastic) and was designed to use a LED instead of a power-consuming backlight.  Otherwise it was expected to be functionally a duplicate.  ASG had been exposed to the previous code and was well equipped to walk through the new code on the new device. ASG was asked to review validation documentation that was being developed by our client.


Project Assumptions:

  • Our client provided a list of documents they needed help with. We started with the VDD, ADD and SDD.  (Version Description Document, Architecture Design Document, Systems Design Document.)
  • Our client was responsible for all validation and verification testing. ASG was tasked with reviewing code and documents.

Due to the “moderate” level of concern assigned to any FDA regulated device that contains software, ASG recognized that a line-by-line walkthrough of the code would be required. ASG proposed that a design review, or walkthrough, be conducted first for the dual purposes of familiarization with the system and to investigate any areas of concern arising from the documented design.


Project Implementation:

The design walkthrough was conducted in collaboration with the client.  A document artifact was generated at the end of the design review stating that the design was evaluated.   Any areas of concern (risks) and any potential areas of improvement were also documented.

Next, ASG performed a code walkthrough with the original developers. As an outside consultant, ASG does not attempt to critique the styles, conventions, methodologies, or other similar non-functional aspects of the code. Instead, ASG focuses on the architectural functionality of the code in terms of one module or function’s interaction with each other, and how the software works as an integrated unit.

ASG, nonetheless, paid attention to any coding standards used to point out any gross deviations from the documented guidelines. Similarly, ASG searched for any potential memory leaks and other general practices that might have led to brittle code.

All walkthroughs were conducted with two ASG engineers.

The conclusion of the code walkthrough phase resulted in a walkthrough document that minimally confirmed the date(s) and time(s) of the walkthrough, the version reviewed, and any items noticed during the process.


Code Review Task Breakdown:

ASG frequently performs both types of walkthroughs using web-based teleconference technologies such as GoToMeeting. As such, travel is generally not necessary for the effort.

Typical Task list for FDA Code Review:

  • Review of Existing Documentation
  • System/Software Design Review
  • Software Code Walkthrough (example 25K LOC, ~400Lines/Hr, 2 ASG Staff)
  • Walkthrough Document Artifact Generation


Other Documents that might be included in an FDA documentation gap analysis:

  • Design & Development Plan
  • Software Requirements Specification
  • Software Description
  • Software Design Specification
  • Architecture Design Chart
  • User Requirements Specification
  • Verification Plan
  • Product Verification Protocol
  • Human Factors and Usability Engineering Plan
  • Human Factors and Usability Engineering Protocol
  • Validation Plan
  • Validation Protocol
  • Software Development Environment Description
  • Software Change Management
  • Software Build Management
  • Software Revision History
  • Software of Unknown Pedigree
  • Unresolved Anomalies
  • Verification Report
  • Human Factors and Usability Engineering Report
  • Validation Report

Read more about ASG’s Software Testing, Verifications, and Validation services.  Contact ASG to speak with a Software Engineer about testing your FDA Device’s development code.