Do you repeat information throughout your documentation submission?

[happylola]

Hi! I was wondering what you do when typical documents require, at some points, the same information. Do you just repeat? Do you mention in one document that the information is in another document? If so, how do you decide which one gets it?

For example, in Risk Management. Do you add your risk matrix in the Risk Management Plan and in the procedure? Do you have a separate document just for your Risk Matrix?

Just curious as to how everyone is doing this.
Have a nice weekend!

 

[Tidge]

We've repeated information, with various levels of detail. Our submissions have included very complete sets of records... sometimes a reviewer asks for (extra) information that we already provided. I pass no judgement, but I think in these cases the reviewer only saw the info in one place and didn't think to look in the other place, even when we provided a near-direct link from one to the other. We are all busy.

I have no way of knowing if a reviewer didn't ask a question based only on the 'first' time they encountered a piece of information.

 

[Thee Bouyyy]

For example, in Risk Management. Do you add your risk matrix in the Risk Management Plan and in the procedure? Do you have a separate document just for your Risk Matrix?

We have separate document available. We mentioned the reference(s) of document in the procedure(s). We tried to avoid duplication in QMS.

 

[Raisin picker]

I usually suggest to have a summary of the data, and a direct reference to the original document. You might want to have a (hidden) backlink so you know which documents are affected when you change the original file.
I've come across TDs with four or five different versions of intended use (not only in wording, but also in content). Not good.
I've also come across TDs where everything is only in one place, and no summary nor reference. Also not good. But these often have much more severe issues ;-)

Always remember MDR Annex II:

The technical documentation [...] shall be presented in a clear, organised, readily searchable and unambiguous manner[...]

 

[chris1price]

Unfortunately some things do get repeated. Its important that you are consistent with what you submit.