Difference between 21 CFR Part 820.72 and 820.70(i)

R

ryno fan

#1
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.
:notme:
thanks
 
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yodon

Staff member
Super Moderator
#2
I guess I'm not clear as to why it matters. I think you have properly understood that both types of software need to be validated. You could make logical arguments either way. Probably more important that you consistently apply your decisions.

Personally, I would say that all the software you mention falls under 820.70(i). But again, in the end, it doesn't matter which clause - you validate.
 
R

ryno fan

#3
Thanks, yodon. I should have clarified my big picture question, which is, on our Audit Schedule we need to include all regs. applicable to us. Should we continue to include 820.72?
 
I

isoalchemist

#4
I'm not sure 870.72 is valid in your case. If all you are doing is running a series of test scripts and validating your medical device produces the correct response, there is no calibration.

If you chose to claim that the computer holding the test scripts needs to be controlled, it would be applicable (870.72a). I've never encountered anyone taking it that far but...
 
R

ryno fan

#5
Also, as a manufacturer of standalone software medical devices, does 820.250-Statistical Techniques apply to us?
 

yodon

Staff member
Super Moderator
#6
Also, as a manufacturer of standalone software medical devices, does 820.250-Statistical Techniques apply to us?
I'd say no. I've only seen that for production processes. While you will have "production processes" (maybe creating distribution media), all that is generally automatically verified and there's no variation in what is done.

In your QMS, you should justify the exclusion with the rationale.
 
R

ryno fan

#7
Thanks, yodon.

On a similar note, when we use sampling plans for internal audits, do the sampling plans need to be based "on a valid statistical rationale"?
 
R

ryno fan

#8
Thanks, yodon. Not that I necessarily disagree with you, but for my understanding I wish to ask: We trend our medical device complaints to determine the most problematic issues in need of CAPA. It has been my understanding that trending, in general, is part of Statistical Techniques, or a type of. Is it called something else?

Also, in the 820.100 CAPA regulation, it states: Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems [in the effort of identifying what "needs" CAPA]. Is this "statistical methodology" part of Statistical Techniques, or is it called something else?

Just trying to learn/clarify.
Respectfully,

"ryno fan"
 
I

isoalchemist

#9
:2cents: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"
 

yodon

Staff member
Super Moderator
#10
Oh, sorry, I was apparently still fixated on 820.72 - the original question about production processes. Yes, absolutely, if you use any kind of statistical method in the quality system, it absolutely should be sound, rational, and defensible. (Thanks, isoalchemist, for the quick correction.)
 
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