Home Forums General Discussion Stability chamber open and close logs Reply To: Stability chamber open and close logs

John O’Neill
Moderator
Post count: 67

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.