Questions about the contents of a Design History File

Hi Everyone

This is my first post, but I've read a *lot* of the posts at Elsmar Cove over the last decade or so.

I've recently started with a company that operates in the In Vitro Diagnostics (IVD) space, particularly providing controls and calibrators for diagnostic devices.
It seems like this is an odd regulatory niche, tacked onto IVD which is tacked onto medical devices. (Please correct me if I am wrong)
But, we from our own understanding and advice from a reputable consultant that we are bound to follow 21 CFR 820 and ISO 13485 based on our target markets.

We went through a retrospective Design History File (DHF) creation project for our products (under change controls for each product family spawned out of CAPA process, and including many notes to file to explain when, what, and why as best we could), and we created these burdensome time-consuming monstrous reports in Excel, that required other excel documents just to create (meta documents that organised data sensibly for the creation of the document).

Each For example, one of the sections of our DHF is an input-output traceability matrix (IOTM). Given that it is retrospective, we unfortunately could not find the inputs as described. One DHF IOTM is about 250 rows, but a row could have 20 lines of text.

Since creating these monsters, and struggling to tame (maintain) them, I've looked more and more into advice from the internet, and I am starting to believe that we might be going too far in some directions - I get that these are big and time consuming, but I wonder how necessary some of the things we are putting in are.

We are moving from excel to an EQMS system, and thus it is a good opportunity to revise our recently created DHFs, and their approach, as we have to recreate them anyway. (I think this is a good idea, am I wrong?)

My questions to this forum are:

Should our design inputs be mostly focused on specific standard and regulations?
(I think not as all advice I have encountered places the focus on what the individual using the product needs, but maybe it's because they were made retrospectively in the absence of defined inputs?)

Should all input materials be detailed in the DHF?
(we have taken every possible material item with a specification associated to a product, and recorded it's specification document as an output, but I wonder if that was appropriate)
To expand:
Specifications for cleaning chemicals used to clean process equipment?
Specifications for parts (e.g. the U.V. lamp replacement for out water system, or a replacement process contact valve) used to maintain process equipment?
Specifications for in-process labels?
Specifications for chemicals used in the manufacture of the product (I think yes to this, but wanted to challenge that)?
Specifications for consumables (pipette tips, cuvettes, propriety cleaning chemicals, reagents specific to analyzers etc) used on analyzers used for in-process or COA testing?

We've been advised to put equipment qualification reports, process validation reports, and test method validation reports as verification and validation activities for various design elements.
I get that we would not do that this way if we were creating a "new product" yet we were instructed (by our consultant) to do it this way. Does this seem sensible to you?

Thanks in advance for your advice, and I hope that I can one day reciprocate.


Ronen E

Problem Solver
Staff member
Super Moderator
No offence, but normally when someone goes to a Doctor, then goes to another Doctor to get a second opinion because they don't trust the first, they'd do their due diligence in selecting the second, and they'd pay that other Doctor for a serious evaluation. They wouldn't approach people on the street and ask them. Right?
Hi Ronen,

Thank you for your reply, and no offense taken.

You raise a good point! I am looking to get my bearings on a relatively complex problem - from my perspective anyway, by seeking comment from industry professionals. I don't seriously expect someone to come along and answer every one of my million questions, or hand hold this organization as we move closer to compliance, I guess I'm looking for a reality check?

Ultimately, we are responsible for our DHFs, and we need to be actively creating them off "our own knowledge" - I realise that on one hand, saying "the consultant said this" isn't owning that responsibility, and saying "people on the internet said this" is even less so, but in the absence of knowledge, what can you do but ask people who know?
And when I know more, I would consider approaching our consultant again, or a new one, if it seems that we do need to course correct.

In the context of your analogy, if I went to a Doctor and did not like their diagnosis, I might speak to someone I trust, or perhaps ask on an online forum first before paying to get a second opinion from a Doctor.

Thank you again.

Ronen E

Problem Solver
Staff member
Super Moderator
There is more than one way to be compliant.
Give me a buzz when you're ready for the second opinion, but only if you are >95% sure that you can trust my advice and won't need a third opinion.

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