Are you searching for the perfect eTMF solution?

This presentation reviews the key attributes that eTMF solutions must have in order to satisfy the regulatory requirements.

This session focuses on a practical approach to selecting a qualified system, and configuring, validating and managing a compliant eTMF.  Review key attributes that eTMF solutions must have in order to satisfy the regulatory requirements and discuss risk-based validation approaches including the validation of off-the-shelf eTMF systems.  Additionally, change management and long-term record retention requirements within systems are examined.  

Key areas of focus include:
•    Performing a qualification audit for system selection
•    eTMF attributes required for compliance
•    Definition of an electronic record
•    Electronic signatures vs. electronic approval
•    Risk-based validation approaches for eTMF
•    Electronic records management, retention and retrieval