Manufacturing vs. Production for Medical Device Software in a FDA context

U

ujain82

#1
Hello All,

I am in Quality role in a medical device software firm. There's always discussion around what manufacturing means to software device.
And what does Production means?
How is manufacturing and production different?

This is my take on this concept:
1) Software development/testing/validation is like manufacturing (similar to a component/HW development)
2) After development is complete, master build (CD) is done. This is where we do DMR (recipe of how/what for a device software)
3) Lastly, replication of CDs (software) is done. I call it a production line. This is where DHR is done.

Please provide inputs to make the process clear. Also if I can get information on the DMR contents in this scenario.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Manufacturing vs Production for Medical Device Software in a FDA context

Hello All,

I am in Quality role in a medical device software firm. There's always discussion around what manufacturing means to software device.
And what does Production means?
How is manufacturing and production different?

This is my take on this concept:
1) Software development/testing/validation is like manufacturing (similar to a component/HW development)
2) After development is complete, master build (CD) is done. This is where we do DMR (recipe of how/what for a device software)
3) Lastly, replication of CDs (software) is done. I call it a production line. This is where DHR is done.

Please provide inputs to make the process clear. Also if I can get information on the DMR contents in this scenario.
Hi,

I come from the medical device field, however not specifically from the software area. FWIW:

- FDA doesn't officially use the term "production" and I'm not aware of an official definition; contrary to "manufacturing", which encompasses both the development of devices and their consequent serial creation (what you call production).

- I'd say your DMR should at least contain or refer to your source code, as well as detailed specification for making the physical form in which the device (software) is delivered to the user - CDs, packaging, labeling etc. Source code to software is like drawings / specs to a physical object, isn't it?

- Your DHR should contain or refer to all data relevant to the actual making of a series of devices (maybe a lot or batch of packaged and labeled CDs in your case). As a minimum I would look for reference to the exact files placed on the CD's, how they were put there and details regarding all consequent manufacturing operations, e.g. packaging and labeling.

Cheers,
Ronen.
 
U

ujain82

#3
Re: Manufacturing vs Production for Medical Device Software in a FDA context

Thanks Ronen for the prompt reply.
I agree to most part. I was trying to distinguish between manufacturing and production but as you specified manufacturing is both development and consequent creations.

Also for DMR contents, does it need to specify procedures for development/testing (along with requirements and specifications) and then procedures/specifications for packaging/labeling.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Manufacturing vs Production for Medical Device Software in a FDA context

Also for DMR contents, does it need to specify procedures for development/testing (along with requirements and specifications) and then procedures/specifications for packaging/labeling.
Hi,

The DMR is the blueprint for making a device version that is already released for marketing. It doesn't need to address actions taken prior to such release, e.g. in the development stage (these would be covered in the DHF and otherwise under design control SOPs). If some testing is deemed necessary through the making of every lot of devices, then such testing is an integral part of the device making and as such is within the DMR's scope. Procedures / specifications for packaging / labeling definitely belong in the DMR.

Cheers,
Ronen.
 
A

ariannas

#5
Re: Manufacturing vs Production for Medical Device Software in a FDA context

I am reading this post with great interest --

Ronen E, can I ask for clarification on something?

- FDA doesn't officially use the term "production" and I'm not aware of an official definition; contrary to "manufacturing", which encompasses both the development of devices and their consequent serial creation (what you call production).

In the QSR regulation, there are several references to "production" and a section that describes production controls. So could you clue me in on what you mean by saying that the FDA doesn't officially use the term?

Like the original poster, I also am wrestling with the precise meaning of what "production" is in the context of a software-only medical device.

I'm not trying to start a debate, I just want to get on the same page as you are...

:D
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Manufacturing vs Production for Medical Device Software in a FDA context

I am reading this post with great interest --

Ronen E, can I ask for clarification on something?




In the QSR regulation, there are several references to "production" and a section that describes production controls. So could you clue me in on what you mean by saying that the FDA doesn't officially use the term?

Like the original poster, I also am wrestling with the precise meaning of what "production" is in the context of a software-only medical device.

I'm not trying to start a debate, I just want to get on the same page as you are...

:D
Fair enough, that was a poor statement on my part.

Obviously the sentence
FDA doesn't officially use the term "production"
Is not true; however, I still back
I'm not aware of an official definition;
The meaning of "Production" can be inferred from the various mentions across part 820, and is, IMO, as I tried to convey in previous posts.

Sorry if I (unintentionally) misled anyone. We all have our days sometimes.

Ronen.
 
Last edited:
A

ariannas

#7
Re: Manufacturing vs Production for Medical Device Software in a FDA context

Ronen E, thanks for letting me know what was up with that.

I SO wish the FDA had defined "production" -- what what seems self explanatory in one segment of the industry can be pretty opaque to others.

The funny thing is, given a regulation that mentions risk analysis only once in the validation section(!), I find it plausible that the concept of production might be covered and then not used. Or that there might be an undiscovered guidance document out there somewhere saying "oh, by the way, we are exercising "enforcement discretion" for subpart G. :rolleyes: Which is why I asked you about your post.

I still go around circles when it comes to linking "production" (and "transfer", and "package") to specific parts of a software development life cycle. My thinking right now is that it almost doesn't matter which term gets slapped onto which process, so long as we define the process, execute the process, and demonstrate that the results of the process are acceptable/valid (and then use CAPA to try and do it better :tg:)

Thanks,
Arianna
 
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