Hi everyone, this is my first post! Hopefully I have put this in the right section and someone can help me.
I am in the process of performing the initial qualification of a pair of cryogenic freezers for storage of GMP materials. Both units feature controllers that will also log temperature data and system events such as door openings and alarms.
I am a little unsure of the requirements for electronic records in GMP-compliant systems, specifically whether if the equipment is qualified (in terms of temperature sensors calibrated against traceable standards and alarms qualified during OQ) whether an electronic record is still required?
If records are required then I am left with a problem in terms of qualifying data integrity.
Thanks in advance for any advice.