DoC for Software Product - How can I identify the specific units that are covered?

A

andreiafilipaf

#1
Hi

I need some assistance regarding the Declaration of Conformity of a software product. My notified body is asking me to make my DoC mention the the specifics manufactured units that it is covering by the serial number, or by LOT. Since we are talking about software, I only have my units prepared once we make a sell, i.e., the CD with the software is only burned at that moment. And it is only a copy of the software that I have in the computer.
I cannot identify the unit by the license keys because they are also generated at the moment of the sale, because the number of users is embebed in that license.

Any ideas?

Thank you!!!!!!!!
 
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sagai

Quite Involved in Discussions
#2
Re: DoC for Software product - how can I identify the specific untis that are covered

Welcome!

Nice subject ;).

It depends on what you consider as part of your device master record, which is the basis of design transfer to manufacturing.
Your options is the:
- source code,
- executable.

In case it is the source code, than at each compilation, somehow you shall identify the executable (in this case, the device master record consist the source code and the manufacturing process contains the compilation of the source code to executable),
in case it is the executable, than each copy to disk should be identified, I guess, this is the one required by the notified body. (actually it is not a bad idea to identify by individual license key, it is looks fine for me)

br
Sz.
 
Last edited:

yodon

Leader
Super Moderator
#3
Re: DoC for Software Product - How can I identify the specific units that are covered

If you follow good software engineering practices (I hope!!) then you should have some kind of release / version identifier for your release (e.g., an x.y.z format is typical to reference the major release (x), minor revision (y), and -shudder- patch release (z)). This identifier can be used to identify, by revision, each element in the build (standard Configuration Status Accounting / Configuration Identification).

I would think this would be appropriate for your DoC.

Side note: I would also hope that the release process itself is well controlled; i.e., you have a dedicated PC for burning CDs and the content comes from a standard release repository (not just whatever happens to be on the computer at the time).
 

sagai

Quite Involved in Discussions
#4
Re: DoC for Software Product - How can I identify the specific units that are covered

Hi Yodon!
Please to see you here again.
I would like to know your view. Do you think the burned CDs also shall be identified regardless they are having the exactly same release?
br
Sz.
 

yodon

Leader
Super Moderator
#5
Re: DoC for Software Product - How can I identify the specific units that are covered

Hi Yodon!
Please to see you here again.
I would like to know your view. Do you think the burned CDs also shall be identified regardless they are having the exactly same release?
br
Sz.
Hi Sagai,

If I understand the OP correctly, the NB is asking for the DoC, not the customer. So...

Should the individual CDs be identified in the DoC? No, as the OP stated, they won't be known at the time the DoC is produced.

Should the individual CDs be identified with the release information? Absolutely! The CD should be labeled with the release / revision identifier for proper management purposes (just like you would any deliverable).
 
A

andreiafilipaf

#6
Re: DoC for Software Product - How can I identify the specific units that are covered

Hi

thank you for the info, but the problem is that the Doc must identify the specific items produced (CD) and not only the version number.
What I proposed to the auditor, and hadn't got his feedback it is have the DoC point to a list of item (CDs) produced for the version of the SW that was CE marked.

regards,
Andreia
 

sagai

Quite Involved in Discussions
#7
Re: DoC for Software Product - How can I identify the specific units that are covered

Thank you for these info, actually this was my impression too.
 
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