Our local sterilizer is closing - Record Retention Question

[katastic2908]

Good Morning,

Our local sterilizer is closing down their facility here, we are in the process of changing facilities.

My question is, our sterilizer is asking if we want our sterilization records from their end, all of their records for the sterilization they performed. We of course have our records and their reports we received from them. These are the processing and validation records for their end on our products (I hope that makes sense).

Do we as the manufacturer need to keep those records?

TIA

 

[ScottK]

Good Morning,

Our local sterilizer is closing down their facility here, we are in the process of changing facilities.

My question is, our sterilizer is asking if we want our sterilization records from their end, all of their records for the sterilization they performed. We of course have our records and their reports we received from them. These are the processing and validation records for their end on our products (I hope that makes sense).

Do we as the manufacturer need to keep those records?

TIA

Do you NEED to... I'm not sure. It might not be required.

But I think it would be a good idea in order to maintain full traceability in case there are things on their records that aren't in the reports they provided to you.

I signed off on many many quality agreements over the years where we committed to device customers that if we were to shut the site down we'd hand over records for their products.