Investing in powerful tools, such as an eTMF system, can work wonders when it comes to ensuring inspection readiness. But without a robust process in place, you can wind up making things more challenging for yourself.
When creating a TMF process, it is important to start from the finish line looking back. You must begin by defining your goals and what you wish to achieve, and then develop the steps necessary to attain your desired results. This can include assessing your current process, identifying stakeholders, creating visual flowcharts, and implementing SOPs and WIs that are aligned with not only your internal quality standards, but also regulatory requirements and GCP.
In this session, we’ll cover:
Key elements for building a TMF management process
How to set TMF management goals
Assessing and identifying gaps in your current process
Identifying stakeholders and creating visual flowcharts
Implementing SOPs and WIs
Негізгі бет TMF Maturity Day - Session 2: Building a TMF Management Process from Start to Finish
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