R
Hi,
I work for a manufacturer of standalone software medical devices. We use many software tools in our quality system...
As examples, we use databases for storage of quality records, and electronic processes for documenting design changes.
My understanding is these are subject to validation under 820.70(i) Automated Processes.
We also use software testing programs to test our software medical device. My understanding is that THESE are subject to validation under 820.70-Control of Inspection, Measuring, and Test Equipment.
My question is: does 820.72 apply to my company based on what I have said? (some have asserted that even the software TESTING programs can be validated under 820.70(i) and therefore, 820.72 would not apply.) Please clarify.

thanks
I work for a manufacturer of standalone software medical devices. We use many software tools in our quality system...
As examples, we use databases for storage of quality records, and electronic processes for documenting design changes.
My understanding is these are subject to validation under 820.70(i) Automated Processes.
We also use software testing programs to test our software medical device. My understanding is that THESE are subject to validation under 820.70-Control of Inspection, Measuring, and Test Equipment.
My question is: does 820.72 apply to my company based on what I have said? (some have asserted that even the software TESTING programs can be validated under 820.70(i) and therefore, 820.72 would not apply.) Please clarify.

thanks
I take a broader view of statistical techniques similar to your's Ryno Fan. Trending of complaints, bug fixes, sampling plans all would qualify under the intent of statistical techiques. You are correct 820.100 support the intent for things other than the classic production statistics to be considered as "satistical techniques"