For the medical device space, the general requirement is that the change control/approval file must contain an exact copy (e.g., identical format, identical content) of what was disseminated/used. Thus, if the actual ad/promo material is disseminated in hard copy format, then the official copy in the change control/approval file needs to be an identical hard copy. However, if the quality system has been validated to be compliant with applicable requirements regarding electronic records and signatures (along with, or instead of, requirements for digital copies of hard copies), then the official change file copy of the hard copy could be a digital copy. Similarly, if the actual ad/promo material is not disseminated in hard copy format (i.e., it's only disseminated in electronic format), then the official copy in the change control/approval file also needs to be in electronic format; but again only as long as the quality system is compliant with applicable requirements regarding electronic records and signatures.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 13-Feb-2024 14:26
From: Anonymous Member
Subject: Ad Promos Materials Regulatory Department Internal Filing Questions
This message was posted by a user wishing to remain anonymous
This is a practical question or an internal practice question on the printed ad promo materials. Typically, when marketing prints any ad promo materials, they will also give regulatory a copy, we regulatory file them in the cabinet, and have been doing this for years and the cabinet is running out of space…also no one ever sees these archived printed ad promo materials anymore, new people just look at the electronic version before it gets printed. I certainly see the value of keeping these printed ad promos' materials in the regulatory cabinets, however at the same time, think it is a waste of time and space, I wanted to reach out to colleagues here to ask if you are still archiving these materials in RA offices physically for the expired ones, and for the newly printed ones, or skipped doing it nowadays? Thanks for any feedback you may have!