Sponsor asked to view our SOPs remotely using File Sharing

N

ngoodall

#1
We are a small but very busy group that performs analysis of medical images taken during the course of clinical trials. We are used to prospective and current study Sponsors conducting audits and site visits; however, we have never been asked before to provide our SOPs for remote viewing. We will have a signed and executed confidentiality agreement in place.
We considered showing documents on our screen via a webinar, such as GoToMeeting, and the Sponsor mentioned a "fileshare." We have worked hard on our procedures and don't want them floating around in cyberspace, but we are also keen to not have Sponsors' representatives physically here.

Has anyone encountered this before, and if so, how did you provide what they needed?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
My understanding is that a fileshare approach from your primary network would be unsecurable. Maybe your IT people would have a differing view.

If you're going to provide access to your information via the net, my suggestion would be to do so from a machine that's not physically connected to your network.

As to providing customers with QMS audit access: we do so only by appointment, within the bounds of a one-day onsite regulatory audit. Our customers wouldn't accept online QMS access as an alternate audit approach anyway, because they want to verify how we implement the procedures, not just what the procedures say.

If you want to keep customers offsite, you're going to have to make some compromises somehow, unless you're willing to tell them they can't audit you.
 
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