Good morning everyone,
My team and I are implementing a new temperature monitoring system (Rees Scientific) for a small GLP/GMP CDMO. The system looks at our CTUs and sends out an alarm when outside of specified ranges. Would love your feedback on two items!
1. What documents are critical from an external auditor perspective? I plan on having the following. Anything else I should consider?
- Change Control to document the process
- Functional risk assessment to compare business/compliance needs against what the system provides (with risk mitigation actions for any gaps)
- IOPQ packet which is performed by the vendor
- Part 11 compliance check
- Software check
- Functionality check
- Documented Training of users and admin
2. Is there a resource I can reference for implementing new systems in a GxP environment? Would love to read up on it.
Hello, We have Rees at my small biotech company. We have a SOP outlining what the different alarms mean. Rees sort of has their own language. For example, we define what a commwatch alarm is, and what must be done to resolve it or how quickly alarm responders must respond. I have def found things in the IQOQ packet that required follow up, so be sure to review and understand while Rees is still onsite. Their tech support can be a bit slow to respond in my opinion. For our training, we require alarm responders to attend the training 1x/year. Some responders rarely have to respond so they forget what to do (enter your pin, etc., when acknowledging a phone alarm). Good luck!
Thank you Jenna. This is very helpful! Can you remember any specific issues in the IOQ packet that I should look out for?
It was something w a generic linear transducer input we have. I can say the packet was well laid out from Rees so I could review the IQOQ and tell something was missing related to this input, without having a lot of knowledge related to the testing that Rees was performing. For example, the IQOQ said something like list the inputs and for each input, this must be attached…and the attachment was missing. So it was easy to fix once we get in touch with Rees and got someone who knew about this test to help us.