Document Revisions Required in DMR Index?

[UncleCrazyHorse]

Hello Covers!

We are a small medical device firm. We are virtual, in that we own the design, registration, etc. but we contract all manufacturing, and perform lot release testing, document verification and final product release. Apart from lot release samples, we never actually see the product.

We are updating the DMR at one of our Contract Manufacturer (CM) facility. The CM has a 21CFR11 Compliant Document Management System. The DMR exists within that system as an index (think BOM indented by sub-assy levels, Work Instructions {WI} and Inspection Procedures {IP}listed with components at the proper indent/sub-assy level).

CM states they do not require the DMR to list the actual Revision Level, and instead contains a pointer to the approved file location within their doc control system for the current revision of each drawing, WI, IP, etc.

Conflict exists around the actual requirement. Some state the DMR must refer to the location of the current file, and hyperlink is not sufficient.
(It seems that belief originates here: 1st Paragraph of DMR section. 3 lines down.)

From reading other discussions in this forum, I believe Revision Control on the DMR is a best practice. As such, whenever a document is added or removed, the DMR must be updated. However, the debate remains on revision levels within the DMR.

My proposal: Identify the actual server location/document ID for each line item in the CM DMR Index, and rely on Doc Control at CM and Internally to assure those are always up-to-date. (Note: we have very good change notification agreements in place, and reliable document review/implementation processes.)

Your feedback on my proposal is greatly appreciated. Also, any comments detailing how you manage this at your firm would be helpful.

 

[Ronen E]

Hi,

Please keep in mind that the DMR regulation was created before hyperlink usage became so prevalent, so I guess nobody actually pondered on such issues for too long, back then. Perhaps it is due for a little update...

IMO what you propose might be a little excessive. I think that the existence of a hyperlink meets the requirement to "specify the location", without spelling it out in an additional form. After all, anyone with proper authorization (e.g. doc control or QA) can interrogate the hyperlink and see the actual server location. Since the system is validated to part 11 I think that this should suffice.

Cheers,
Ronen.

 

[UncleCrazyHorse]

Thanks, Ronen E! For what it's worth, I sold them on the idea that the hyperlinks address the "location" requirement within the guidance.

I also sold them on the DMR matrix being revision controlled, but that revision would only change if a document is added or removed. The DMR revision would not change if a document within the DMR was revised.

There is still debate on configuration management, Revisions on BOMs, whether the BOMs revise as sub-components are revised, but that's a topic for another forum discussion altogether.

 

[Ronen E]

I am guessing that the part 11 doc control system records / indicates the MDR revision history anyway, including every revision of any of its ingredient items (naturally, addition/removal is a "revision" of the item). It may not be called "A Revision" and may not show on a printout of the DMR (if one is available as such) but I'm guessing that it is in the system and that it can be traced back by the operators.

Cheers,
Ronen.

 

[Oscar Wang]

Hello everyone, i am a freshman in this forum. my question is that Is it necessary to maintain a DMR index if a sophiscated documentation control system exist. We can run a E-BOM explosion survey and get a whole assembly BOM structure including all sub-levels components like a tree structure and associated DMRs in the report.

 

[Oscar Wang]

Because there are a lot of design changes happening now and then, DMR index will also change from time to time. what is the purpose of maintain this index? I think this task is burdensome and has no significant meaning.

 

[Ronen E]

Hello everyone, i am a freshman in this forum. my question is that Is it necessary to maintain a DMR index if a sophiscated documentation control system exist. We can run a E-BOM explosion survey and get a whole assembly BOM structure including all sub-levels components like a tree structure and associated DMRs in the report.

A DMR is more than just a BOM, typically.

 

[Ajit Basrur]

Because there are a lot of design changes happening now and then, DMR index will also change from time to time. what is the purpose of maintain this index? I think this task is burdensome and has no significant meaning.

Thats the law -

Refer 21 CFR part 820.181

 

[Oscar Wang]

Thanks Ajit. We are using Agile system. I am not sure whether you are familiar with this PLM system or not. In this system, each part has its own BOM and DMR, all of them are sequenced with an index number and listed underneath this part. When a BOM survey is executed, all these information can be retrived from the PLM database and generate a report. It's not only a BOM.

 

[Oscar Wang]

by the way, i checked the regulation clause and its preamble and didn't find the requirement for DMR index. FDA just required the DMR shall be reviewed and approved up on review matrix according to documentation control and it shall be maintained and updated properly. Whether there is an index or not may be not critical to them.