Home Forums General Discussion The Situation Room: Chamber Log Books

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  • John O’Neill
    Post count: 73

    Read: Chamber Log Books: Maintaining Documentation

    How would you respond to this particular situation? What insights can you provide? What questions you do have for experienced stabilitarians?

    Post count: 3

    If there is an environmental monitoring system that shows all of the data and only the excursions are documented in the use log, would it be appropriate to refer to the environmental monitoring system data to show what (if any) excursions there have been? If there had been an excursion, was a Quality event (deviation, nonconformance) created that includes a product impact assessment? If so, you could pull all (if any) Quality events, too. The ems data and the Quality events together should tell the story of product integrity. The only data that would be missing is the actual open and close events, but if there were no excursions more than 1 hour and you don’t accumulate excursion times and adjust study durations accordingly anyway then those open and close events shouldn’t matter.

    Is the ems data reliable?
    Are you creating Quality events for actual excursions?
    If you are not accumulating short excursion times and adjusting study durations accordingly, then why do you need to track opening and closing the door?
    What is the logbook getting you that the ems system and Quality event isn’t? Maybe you don’t need that logbook if it’s just a transcription of data already captured somewhere else.

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