Feb

2003

Quality System Information for Premarket Reviews

Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews
Issued: February 3, 2003

The following are software related excerpts found in this document:

“If the device is automated with computer software, you should explain how you have (or will) complete your software validation, and include any system integration testing.

Your process validation master plan or your description should also include any validations of software used as part of the production or quality system. (See 820.70(i))”.

The full guidance is at the link provided.

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