DHR (Device History Record) for Medical Device Software

I

ic007832

Guest
#1
Hi,

I have read lots of things about DHR which is applicable to manafacturing industry(medical device).
Can somebody help me in understanding following question about DHR for software industry(medical device).
What is DHR?what is the intended of DHR?What DHR should contain for software product?

Thanks
 

Stijloor

Super Moderator
Staff member
Super Moderator
#2
Re: DHR for software

Hi,

I have read lots of things about DHR which is applicable to manafacturing industry(medical device).
Can somebody help me in understanding following question about DHR for software industry(medical device).
What is DHR?what is the intended of DHR?What DHR should contain for software product?

Thanks
Welcome to The Cove Forums! :bigwave: :bigwave:

DHR = Device History Record.

I leave the rest up to the medical device experts here at The Cove...;)

Stijloor.
 

bio_subbu

Forum Moderator
Moderator
#3
The intent of the DHR (Device history Record) is to provide evidence that the device lot or batch was manufactured in accordance with the DMR. Though minimum requirements for a DHR are identified in 21 CFR 820.184, it is not uncommon for a DHR to contain or reference the following information (as applicable to the product manufactured).

1. Details of Finished device batch, lot or serial number
2. Materials used and may identifiers (part number, control number)
3. Manufacturing dates
4. Quantity started and completed
5. Quantity released
6. Details of testing and inspection records
7. Primary Labeling
8. Identification of individuals performing the operations
9. Documents utilized
10. References to appropriate nonconforming material reports.

If software is part of the device, the details of the software version, assembling in to the device, results from evaluating the device software, will be included in the DHR and it’s provide a manufacturer with traceability.

Thanks and Regards
S. Subramaniam
 
Q

QA_RA_Lady

Guest
#4
I *THINK* we're talking about software AS the device, not just part of the device...

First of all, is this software only, or hardware and software?

Then the rest of the DHR is going to depend on your repository info....
I've done the batch number as the release number down to the build (at a few companies)
I've also worked at companies where they have a ERP that the ISO or executable is checked into and that unique identifier becomes the batch number.... I never really wrapped my head around that methodology.

Usually your materials used would be a list of 3rd party apps (including version) included in your software product, your build system, anything used to write the code

Quantity is usually tied directly to license generation (digital or physical, depending on what you use)

Testing and inspection is your sw v&v and installation v&v records... unless you are mfg hw too -then you need the production info as well

labeling is obviously your GUI, User Manual, Release Notes,etc.

Hope that helps
 
Q

QA_RA_Lady

Guest
#5
Oh - and most importantly... a traveler of some sort... what ever is used to document that each unit was build and tested correctly... so with software this would be the lisc generation and cd creation... if no CD (electronic distribution) these should be someone on site doing a check sum or the like verifying that the right thing was built... if hw is also included it's that and that the box, work stations, whatever, was built and tested by mfg....
 

Chris Ford

Quite Involved in Discussions
#6
The intent of the DHR (Device history Record) is to provide evidence that the device lot or batch was manufactured in accordance with the DMR. Though minimum requirements for a DHR are identified in 21 CFR 820.184, it is not uncommon for a DHR to contain or reference the following information (as applicable to the product manufactured).

1. Details of Finished device batch, lot or serial number
2. Materials used and may identifiers (part number, control number)
3. Manufacturing dates
4. Quantity started and completed
5. Quantity released
6. Details of testing and inspection records
7. Primary Labeling
8. Identification of individuals performing the operations
9. Documents utilized
10. References to appropriate nonconforming material reports.

If software is part of the device, the details of the software version, assembling in to the device, results from evaluating the device software, will be included in the DHR and it’s provide a manufacturer with traceability.

Thanks and Regards
S. Subramaniam

I believe this is a software device - not necessarily software as part of a device, since this is a software company. These requirements for DHR are still applicable.

For software devices, DHR's usually identify the production part number for the software, list the parts (executables, media, instructions, etc), the procedures for "manufacturing" (how the software is copied and packaged, issue of serial number, etc), QC testing procedures, and final acceptance procedures. Of course... dates and individuals performing all of these activities are recorded in the DHR.

Depending on how your procedures are written, you can construct a DHR to suit your needs. I've seen DHRs as one or two sheet summaries, and I've seen them actually include the procedures used for that batch.

Your DHR could represent a single serial number or a batch of serial numbers, again depending on how you've defined your manufacturing process.

In the end, the intent of the DHR is to record the manufacturing and acceptance activities. It should paint a clear picture of the entire manufacturing process from the issue of components to the final release, and will describe all of the material, equipment and processes used for that batch to assemble, test, and release the product.
 

sarkalgud

Starting to get Involved
#8
This is a very interesting discussion.

Is DHR applicable for hosted software (Software as a Service) and Mobile Applications that are downloaded from App Store? Such software is not manufactured and distributed (unlike the software on media/CDs). Hence, I am inclined to think that DHR is not applicable to software that is downloaded on internet (like mobile apps) and software as a service (like websites that can be used to view medical reports which aid in treatment change)

Thanks!
 
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