DMR - Device Master Records - What is the best way to structure the DMR

M

MIREGMGR

#31
Note that with electronic-only records, the FDA will expect you to comply with 21 CFR Part 11 if you have only electronic proof of dated approvals where necessary. Both the FDA and your NB will expect you to utilize validated software/hardware.
 
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T

The Capt - 2011

#32
This is becoming more of a headache than it may be worth.

:truce:

I am basing the DMR's on a "family" grouping of part, i.e. each family has 6 colors, each color has 6 configurations, each configuration has 6 different thicknesses. So we are basing the DMR's on family because they all use the same base material and follow the same process to be produced.

Wrong or right?

Ideas?

Oh and there are minimum of 4 "faimlies" with in one program and there are 15 programs as of right now that are our biggest item.
 
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C

Chris Ford

#33
This is becoming more of a headache than it may be worth.

:truce:

I am basing the DMR's on a "family" grouping of part, i.e. each family has 6 colors, each color has 6 configurations, each configuration has 6 different thicknesses. So we are basing the DMR's on family because they all use the same base material and follow the same process to be produced.

Wrong or right?

Ideas?

Oh and there are minimum of 4 "faimlies" with in one program and there are 15 programs as of right now that are our biggest item.
Disclaimer: I didn't read this entire thread... I was initially intrigued by it, because I noticed it was started in 2004.

At any rate, I've worked with a lot of products that were sold under multiple configurations.

In most cases, we used a top-level part number to identify the base (unit). Then created a DMR that referenced that base number, plus the items in the particular configuration.

It's a pretty simple way of putting a DMR together without having to keep track of dozens of documents to update when you make a change to that base model.
 
T

The Capt - 2011

#34
That's basically the way I wanted to handle it, but didn't really know if it would leave any gaps.
 
C

Chris Ford

#35
That's basically the way I wanted to handle it, but didn't really know if it would leave any gaps.

In my opinion, it's the cleanest, most efficient way of doing this. One step better would be to forget about a separate document called, "DMR" and include everything in your ERP system or document management system. A few companies I worked for used Agile for document and product life cycle management. It was great, because we built DMR's like BOMs into the system. The DMR was always up to date, and we never had to worry about missing any details.
 
T

The Capt - 2011

#36
I definitely see using the MRP system as a good way of handling it, unfortunately our MRP system is not that robust.
 
G

greatJohn

#37
Note that with electronic-only records, the FDA will expect you to comply with 21 CFR Part 11 if you have only electronic proof of dated approvals where necessary. Both the FDA and your NB will expect you to utilize validated software/hardware.
When speaking of software/hardware are you talking about software licenses and where software is hosted, backed up and maintained?
Are there any requirements as to mentioned above aspects set by ISO or FDA?

What branded packages or combination of packages are you guys using in your QMS?
 
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M

MIREGMGR

#38
When speaking of software/hardware are you talking about software licenses and where software is hosted, backed up and maintained?
No. Validation has nothing to do with licensing, hosting, backing up and other operational issues. See the FDA web site for "software validation".

Are there any requirements as to mentioned above aspects set by ISO or FDA?
Not that I'm aware of.
 
T

teqp1

#39
I know this is an older thread that still has some life, so I thought I would post my question on the thread.
I have a co-worker who is of the opinion that we can say that our DMR is located in our controlled documentation system and a "list" is not necessary. The problem I have with this is that without a list to the SOPs and specifications, how do you say you meet the QSR requirement for a DMR? I was always trained that the DMR is a "recipe" for building a device. And I have seen lists or use of travellers or shop orders as the DMR as they list the SOPs, specification on them.

Has anyone used the controlled documentation system as the DMR for a device. I understand that all documents (SOPs/Specs) need to be a controlled document but don't you need an actual list for the DMR or a placeholder to point people in the correct location for the DMR documents?

Thank you for your opinions.
 

GStough

Staff member
Super Moderator
#40
I know this is an older thread that still has some life, so I thought I would post my question on the thread.
I have a co-worker who is of the opinion that we can say that our DMR is located in our controlled documentation system and a "list" is not necessary. The problem I have with this is that without a list to the SOPs and specifications, how do you say you meet the QSR requirement for a DMR? I was always trained that the DMR is a "recipe" for building a device. And I have seen lists or use of travellers or shop orders as the DMR as they list the SOPs, specification on them.

Has anyone used the controlled documentation system as the DMR for a device. I understand that all documents (SOPs/Specs) need to be a controlled document but don't you need an actual list for the DMR or a placeholder to point people in the correct location for the DMR documents?

Thank you for your opinions.
It has been my experience that the DMR is a list, but perhaps there are others who have had different experiences...

I agree that the DMR is a "recipe" (I like that! :agree1:) for building/making a device. The list identifies the document (procedure, spec, etc.) necessary for the making of the device and also the location of those documents.

I'll be interested to see what others say, as well....
 
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