Design History Record (DHR) Format

Hello Everyone,

I am new to the role who is handling DMF, DHF, DHR. I figured quite few things through resources. But i am stuck on Design History Record my Design History File is ready now can anyone help me with some format or any guidelines which can help me progress in my work

Thank you in advance

There isnt a Design History Record, the DHR is a Device History Record - See 21CFR184

The TLA (Three letter acronyms) can be very confusing!

• DHF - Design History File - what you are designing
• DMR - Device Master Record - the outputs of the design, that define what you are going to make (BoM, procedures etc)
• DHF - Design History Record - the details of what you actually did make (batch record, release data etc)

chris1price said:

There isnt a Design History Record, the DHR is a Device History Record - See 21CFR184

The TLA (Three letter acronyms) can be very confusing!

• DHF - Design History File - what you are designing
• DMR - Device Master Record - the outputs of the design, that define what you are going to make (BoM, procedures etc)
• DHF - Design History Record - the details of what you actually did make (batch record, release data etc)

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I think you missread what i have written

nehalmahajan55 said:

I think you missread what i have written

Click to expand...

What @chris1price is pointing out is that you have confused terms and we're not clear if you need help on the Design History FILE (DHF) or Device History RECORD (DHR).

yodon said:

What @chris1price is pointing out is that you have confused terms and we're not clear if you need help on the Design History FILE (DHF) or Device History RECORD (DHR).

Click to expand...

Really sorry it was a mistake from my side I need help with Device History Record (DHR).
i am stuck on Device History Record my Design History File is ready now can anyone help me with some format or any guidelines which can help me progress in my work

Thank you in advance

The Device History Record is your evidence that the DMR was followed. The DMR is the "recipe" for making the devices so your DHR will effectively be derived from your DMR. Your DMR will (reference procedures that) drive all the in process and final acceptance tests, for example, and the DHR will capture the results and the individual performing the tests. (There's more to the DHR but that's a fairly easy, concrete example).

DHF - Coca-Cola - A carbonated Beverage

DMR1 - Original Coke
DMR2 - New Coke
DMR3 - Coke Zero

DHR - Coke Zero Produced using DMR3

Date of Production 5/13/24 Location: 12345 Lincoln Parkway Chicago Illinois USA. Line #3 was utilized. Joe S, Susan E, and Frank T were operators. Yield 98%. Can Lot # A22344XD Expiration Date 5/2028 - Deviations - None, Samples retained 25