Comply with 21 CFR 11, but no other FDA regulations?

OccamMan

Involved In Discussions
I'm a medical device systems engineer who's gotten pulled in to regulatory work over the past few years, so I may have some gaps in my knowledge on non-device stuff...

I'm working with a new outfit that's bringing software and a hosted database to market which captures info from a PACS system, makes some calculations, results are reviewed by a doc then stored in the database for use in longitudinal studies. As far as their regulatory needs, they say that customers are asking for 21 CFR 11 compliance, but nothing else involving the FDA. I'm a little puzzled by this, as my understanding has been the 21 CFR 11 only applies to electronic signatures needed to fulfill *other* FDA regulations (a.k.a. predicate rules). Seems odd that anyone would want to *only* adhere to electronic signature regs when what they're signing is (claimed to be) not under FDA's jurisdiction.

This customer's product will likely be used to produce and store data for clinical trials, so at that point I suspect that their customers will want full FDA-level QMS, design controls, verification and so forth. But for now, they believe they only need 21 CFR 11. Does that make sense?

Also, if they claim adherence to 21 CFR 11, will they be implying a level of validation and control of software and tools that complies with FDA regs for their products intended use?

Thanks in advance!
 

sagai

Quite Involved in Discussions
Re: Comply with 21 CFR 11, but no other FDA regs?

hello there!
I think you are well spotted this subject, I 100% agree with you.
It sounds more like a question of proper customer communication rather than any non-sense kind of work on your engineering department.
Your customer is the one who is liable to comply with any CFR, not you. They need to make sure that the system they use for whatever purpose is compliant.
The other thing is in case it is a tailor made application, engineering benefits of being open and communicative to reasonably customer requests of course.
Again, I think you as an application developer can not claim compliance over your application for part11.
Cheers!
 

OccamMan

Involved In Discussions
Re: Comply with 21 CFR 11, but no other FDA regs?

Thanks!

While we're not responsible to the FDA for ensuring compliance, the customer would like our opinion on what's needed for the development effort to be compliant to 21 CFR 11. If we need to comply with the entire FDA QSR for software development, it will be a much larger effort than if we don't. So I guess the real question is, if the customer wants to claim compliance to 21 CFR 11 do we really need to meet the full FDA QSR for software development?
 
T

Trackerii

Re: Comply with 21 CFR 11, but no other FDA regs?

Thanks!

While we're not responsible to the FDA for ensuring compliance, the customer would like our opinion on what's needed for the development effort to be compliant to 21 CFR 11. If we need to comply with the entire FDA QSR for software development, it will be a much larger effort than if we don't. So I guess the real question is, if the customer wants to claim compliance to 21 CFR 11 do we really need to meet the full FDA QSR for software development?
Is your product a medical device, under Medical Device Data Systems (MDDS)?
 

OccamMan

Involved In Discussions
Re: Comply with 21 CFR 11, but no other FDA regs?

Is your product a medical device, under Medical Device Data Systems (MDDS)?

The customer's position is that it's not a medical device, as its use is for research rather than clinical decision making and treatment. They've been advised to work with a regulatory lawyer to have all assumptions validated before work starts.

However, in the future, it might be used to support FDA applications for approvals, and my experience is at that point it must follow FDA QSR to ensure that the data it produces are good.
 
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