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  • tn58 replied to the topic Discussion Topic: GMP's in the forum Introduction to Project Management 8 years, 6 months ago

    I would like to share my interview experience on this post. I was interviewed for a position and the manager specifically asked me about GMP and what it meant. So in the real life examples, a company must be able to provide a chain of custody of each product or sample in their possession. I would argue that Traceability influences a project in the initiation, planning, execution, closing, and monitoring/controlling phases. Any project would require an actual product or samples for clinical trials. The Traceability will be the key component if your project faces any legal issues because the chain of the custody will be the first under review if anything or any piece of the project is unaccounted for even for a couple hours. The project team must be able to account for the samples or pieces at ALL times. In addition, if under FDA review, your traceability will be looked at in order to detect fraud of falsified documents or results. Therefore, it will influence any project the most.