Delivery Confirmation? Do we need to save?

Pmarszal

Involved In Discussions
#1
Hello,

Does any ISO 13485 or 21 CFR 820 require us to save delivery confirmations? In example, do we need to save the delivery confirmation from FedEx for product that is shipped?

Thanks
 
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RoxaneB

Super Moderator
Super Moderator
#2
Hello,

Does any ISO 13485 or 21 CFR 820 require us to save delivery confirmations? In example, do we need to save the delivery confirmation from FedEx for product that is shipped?

Thanks
Hi, Pmarszal.

I'm not familiar with what those standards say, however, presuming you're in the medical device field, it seems to me to be a good business rule to save them.

What if a Client says they did not receive the shipment? How would you prove that it was shipped and delivered? Personally, I would not rely on FedEx to either save these records for you nor would I expect them to sift through their records if you need to locate evidence of said shipment/delivery.
 

Golfman25

Trusted Information Resource
#3
Hi, Pmarszal.

I'm not familiar with what those standards say, however, presuming you're in the medical device field, it seems to me to be a good business rule to save them.

What if a Client says they did not receive the shipment? How would you prove that it was shipped and delivered? Personally, I would not rely on FedEx to either save these records for you nor would I expect them to sift through their records if you need to locate evidence of said shipment/delivery.
Actually these records are online for several months - i think like 6-12 months. So no reason to keep them in hard copy unless required by something else.
 

RoxaneB

Super Moderator
Super Moderator
#4
Actually these records are online for several months - i think like 6-12 months. So no reason to keep them in hard copy unless required by something else.
OP does not indicate saving them via hard copy. E-confirmations are possible, I believe.
 
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