Paper based DHF (Design History File) updates for Software Updates

H

harneet

#1
We have a paper based DHF. DHF contains the information of the software version which was released when the product was shipped to the client. However the updates to the software product are made onsite and there is a lot of overhead in updating the DHF as its a manual paper based system, which inturn is affecting the traceability.

Can someone suggest a better approach for tracing the software version??
 
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yodon

Leader
Super Moderator
#2
The content of the DHF is the same irrespective of whether you manage it electronically or as hardcopy.

Sounds to me like the process you've chosen is extremely risky. If you make all changes at the client site, how do you fold those back into the baseline? How do you know the software was properly built? I hope there's only 1 client as trying to do this at multiple client sites would be a nightmare!

Maybe if you can be more specific on what your issues are, we can offer some suggestions.
 
E

esalsan

#3
The content of the DHF is the same irrespective of whether you manage it electronically or as hardcopy.
True. However, asking a computer engineer to fill in a paper record is hard to achieve.

Not sure what information are you trying to include in your DHF, but it sounds like the overhead is about duplicating the information (from the place you originally get it from to the DHF), maybe adding a reference to the "original" record (if this is the problem) will help.

21 CFR 820.30(j) says "Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."
 
T

TAllen

#4
Don't know if I'm posting this in the right spot?

Okay I have a question for you that I was hoping you could give me some insight or direct me to a location where I could get some help on this. The scope of our registration is with an analytical scanner which is used in unison with software developed here at our company. The big issue I have with this is surrounding the DHF and how to continually update or revise the DHF because this software is continually expanding. To give you an example the first four platforms we launched were for products A, B, C, & D with specific installers and templates within the software. Now we are adding products E & F to this which is are additional platforms but the installers and templates are different for this. The original 4 were a version 1.0 and now with products E & F it is version 2.0, but again have additional features that are not included on the original 4 platforms. They are all based upon the same scope but trying to figure our how to manage the DHF with these type of changes is difficult at best because your not changing everything. I thought it best to create separate DHF's for these but my regulatory body suggests keeping it all in one DHF because they are all covered under the scope of the initial product. Is there anything you could give me to help with this or direct me to some sources that I could get some additional help with this?
 
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