One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.” This guidance document has been around for many years. The current version, 2.0, was released in 2002. To many in the industry, this guidance is simply referred to as the “GPSV.”
The guidance has a self-stated purpose to provide “validation principles that the FDA considers to be applicable to:
- the validation of medical device software or
- the validation of software used to design, develop, or manufacture medical devices.”
Of course the agency has quite a challenge in providing these principles. One challenge is that medical device software can range widely in complexity and safety risk. Consider what validation principles might be applicable to software controlling hemodialysis sub-systems compared to software displaying a patient’s weight in a scale. A second challenge is how software technology and methods can change rapidly – so principles must stand the test of time. Our opinion is that the GPSV meets these challenges well. It remains a solid text for orienting, on-boarding, and referencing for software validation.
You can download a copy here: 2002-01-General Principles of Software Validation-Final Guidance
Of course, IEC 62304 is the more current, state-of-the-art thinking in the area of medical device software process. One should use IEC 62304 as the basis for software process but we would recommend exploring how the GPSV can give greater insight into greater software quality. Just a quick example is “test types.” This is not found in IEC 62304 but is an essential technique in test case design for developing high quality software.
If you are interested in learning more, consider our 62304-FDA Compliance Training and other courses.