SW (Software) - Customer vs. Company Installation

S

Silvertabb

#1
I realize that if SW is provided on a CD directly to Customers for installation on computer to support their medical device, the Sponsor must demonstrate compliance to the applicable parts of 21 CFR 820. The sponsor must have labeling on how to use the software, have CD labeling, tracking information, and inventory of CDs. If instead of relying on customers to install the SW on their computer the Sponsor provided this service to customers through their trained authorized personnel, will their be a reduction in the number requirements that need to be met or adhered to?
thanks.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
I realize that if SW is provided on a CD directly to Customers for installation on computer to support their medical device, the Sponsor must demonstrate compliance to the applicable parts of 21 CFR 820. The sponsor must have labeling on how to use the software, have CD labeling, tracking information, and inventory of CDs. If instead of relying on customers to install the SW on their computer the Sponsor provided this service to customers through their trained authorized personnel, will their be a reduction in the number requirements that need to be met or adhered to?
thanks.
Any medical software experts that can help?

Thank you!!

Stijloor.
 

v9991

Trusted Information Resource
#3
Most Probably NOT; If I understand your query correctly, Requirements still have to be met with.

The answer is in the rationale of the requirements of manual/help-labeling-traceability-reconciliation. Each one of them are most probably related to change management;(linked with the configuration/release/patch management)

hope that helps.
 
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