Question: My organization is interested in using some of the KCS methodologies, but our compliance team has blocked us from proceeding.
We provide support and service to FDA medical devices, and currently we have support and service teams where the individuals are all utilizing their own personal knowledge (notepad files, onenote, access DBs, etc). We were going to begin documenting our calls in such a way that they get flagged for review by our subject matter experts, who correct/modify and then approve for publishing (internally) so they can be searched and used by our support and service teams.
The compliance team says that these published calls can't be created/used, but turns acknowledges that there's no regulation on each person having their own notes.
I worked at a previous organization where this very same issue was raised, but eventually the legal team was provided with something that allowed them to approve the process. I wasn't part of the legal discussions at my prior organization.
Can anyone provide any kind of reference to a webpage or KCS resource that I could have our legal team evaluate to understand the value and legality of KCS in a FDA regulated environment? To be clear, none of the cases will ever be made customer-facing (everything will stay internal). Thank you.
- David Kay and Andrea Campbell