| Description |
Providing a step-by-step foundation for complying with FDA’s guidance on Electronic Regulatory submissions and 21 CFR Part 11, this training course focuses on how to implement a quality Electronic Data Capture and management systems. Learn how to develop an infrastructure that will allow for a smooth transition from a traditional data management environment to a reliable and effective Electronic Data Capture system. This comprehensive training analyzes Part 11 and teaches specific steps to improve foundation practices that support regulatory compliance. Specifically, the course presents strategies for maximizing data quality, ensuring system and data security and integrity, as well as avoiding compliance pitfalls. Further details of maintaining archived re cords and utilizing hybrid systems are reviewed through case studies and interactive exercises.
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