I wanted to get the forums opinion on using ‘computer generated trend data report from a SCADA’ (which has been fully validated) for a given equipment, versus recording data in person in the field?
We have a bioreactor skid connected to a computer system that logs data every one (1) minute on Temperature, DO, agitation, gas flow and pressure over time. This is the design of the system. My colleague developed a test script for the OQ on bioreactor that requires the executor to record temperature data every 30secs for a duration of 10mins.
My argument is that we do not need to record this data every 30 sec for a duration of 10 mins, since we already have a validated computer system. I plan to use the trend data from the computer system which logs data every 1 minute but over a longer duration in place of an executor recording data in the field. However people are uncomfortable because they do not think it is appropriate to just use the validated computer printout.
I have challenged them on why they think it is inappropriate and I get answers such as:
FDA will always like to see a handwritten data (I disagree because 21 CFR part 11 came out for a reason)
They will like to see what happens between the one minute when computer is not logging data (I reminded them that we have a life cycle approach on this project, which also include but not limited to commissioning, tunning etc. In addition we have alarms that have been validated on this system, so if temp excursion is an issue it will trigger an alarm anyway. Also if what happens in between the one minute is an issue then we should change our requirements and spec to sample data at shorter intervals).
So what are your thoughts on this matter? Do you think my ideas are bizzare?
Mr Stephen N. U Nwodo PMP, ASQ CSQE
Member of Biochemical Engineering SG of IChemE
Affiliate Member Institute of Chemical Engineering (IChemE)
Cell phone:909-732-2885 (USA)