Home › Forums › General Discussion › Stability chamber open and close logs

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  • John O’Neill
    Moderator
    January 31, 2023 at 9:23 am
    Post count: 85
    #22549

    Thanks for participating in the Situation Room Missing Chamber Log scenario. There are 483’s for lacking a chamber flow of custody showing that samples went in and out according to procedure and when, why, where and with whom they went. Many companies exempt door openings and in the case of the scenario, that practice had been successfully defended, but it’s a great “compliance confidence” builder if you can show the duration and impact of door openings in answer to what is becoming a more common question by regulators. These days, there are ample electronic solutions to monitoring these aspects. If budget and quality compliance priorities allow, electronic systems for inventory and chamber conditions/events are definitely on trend.

    Walter Routh
    Moderator
    February 1, 2023 at 11:38 pm
    Post count: 51
    #22550

    So, as far as guidances, no, I’m not aware of a specific requirement to have open/close logs, but as was previously stated, chain of custody and sample integrity are requirements. As such, some access control or documentation would be part of that, but I’m surprised at the details being documented. I believe simply a name and time should be sufficient since the temperature at that time should already be noted, assuming you’re continuously monitoring (a requirement). Also, it seems unnecessary to document the reason for entry since presumably access is limited to qualified personnel and they’re performing routine stability activities. Either way, the reason is immaterial to how the chamber behaves.

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