Acceptable OQ for retrospective -80 Freezer

GOOD DOCUMENTATION PRACTICE (GDocP) OQ (OPERATIONAL QUALIFICATION)
1

Hello to all

I am trying to OQ a -80 freezer for QC purposes in the medical device ISO 13485 environment.

Could anyone suggest a data logger that is capable of dealing with the lockable (tightly closing) doors?

And could anyone suggest a protocol baring in mind material is actually in the freezer and can not be taken out? Just the time span and acceptable temperatures would be fine.

Thanks in advance.

2

You need to look to Wireless Kaye validators and Ellab systems.
They work in low temperatures too.

3

Messa Lab data loggers…TMI Orion data loggers…