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We are a small biotech running multiple global late stage trials, and I can’t seem to convince our QA department that they need to track and report on cumulative time out of storage / refrigeration for our products. I’ve escalated this internally, citing potential issues with efficacy data, or an obvious lack of appropriate oversight and control of our supply chain. Nothing has worked! Can anyone recommend something else I can share with them that may be more effective? Can you put me in touch with someone on your QA team who may be able to talk some sense into them?
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