Continuous Integration on Software Medical Device Projects, Part 9

Using a CI Environment to Replace the Traditional DHF

Naturally, an important part of continuous integration is having a CI build that can be checked regularly for continued build success. This is probably what is commonly though of as the key benefit, but there is much more to be gained. Any continuous integration environment that is worth using will allow the team to incorporate packaging of key project items with each build. This includes important documents, tests (both manual and automated test outcomes can be packaged), requirements, design specifications and build results (deployment packages, libraries, executables, installers, etc.). The important thing to note here is the fact that, used wisely, the CI environment can provide a snapshot of all project outputs at any given point in time. Hopefully it is becoming clear that this gives us the possibility of automated DHF creation. Not only that, we have a much more detailed DHF throughout the life of a project and not merely at a point in time in which a particular freeze was performed.

Tests

The continuous integration server should include unit tests (and by unit tests, I mean functional level automated tests) that provide a level of self-testing code such that any build that fails to pass these tests at build time is considered a failed build.

Packaging

 Continuous integration output need not (nor should it) package only built objects. We can leverage CI build integration with our version control system to package everything required per our design outputs (21 CFR Part 820.30 supbart C (d)), design review (21 CFR Part 820.30 supbart C (e)), design verification (21 CFR Part 820.30 supbart C (f)), design validation (21 CFR Part 820.30 supbart C (g)), design transfer ((21 CFR Part 820.30 supbart C (h)), design changes (21 CFR Part 820.30 supbart C (i)) and even our design history file (21 CFR Part 820.30 supbart C (j)).

Read it all:

[CI on Software Medical Devices, Part 1]
[CI on Software Medical Devices, Part 2]
[CI on Software Medical Devices, Part 3]
[CI on Software Medical Devices, Part 4]
[CI on Software Medical Devices, Part 5]
[CI on Software Medical Devices, Part 6]
[CI on Software Medical Devices, Part 7]
[CI on Software Medical Devices, Part 8]
[CI on Software Medical Devices, Part 9]

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