Computer systems used in conducting clinical trials must be evaluated to determine the level of compliance, established on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems. This webinar will also focus on 21 CFR Part 11 and the significance of managing electronic records and signatures appropriately. We will cover all the essential clinical trial files that must be maintained before, during and after completion of the trial in the Trial Master File (TMF). This discussion will take you through the use and transition to an electronic Trial Master File (eTMF) system. The pros and cons will be evaluated. Finally, how to prepare for a computer systems FDA inspection and its data used to support clinical trials will be discussed. Due diligence is extremely necessary to ensure data integrity is maintained throughout its life-cycle.
Areas Covered in the Session :
- Learn how to identify “GxP” Systems
- Discuss the Computer System Validation (CSV) approach based on FDA requirements
- Learn about the System Development Life Cycle (SDLC) approach to validation
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
- Understand how to maintain a system in a validated state through the system’s entire life cycle
- Learn how to assure the integrity of clinical data that supports trial work
- Discuss the importance of “GxP” documentation that complies with FDA requirements
- Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your clinical trial systems in a validated state
- Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
- Know the regulatory influences that lead to FDA’s current thinking at any given time
- Learn how to prepare the essential files for a Trial Master File
- Understand how an electronic Trial Master File (eTMF) can improve trial management
- Know the clinical data files that are essential to collect before, during and after the conduct of a trial
- Learn how to best prepare for an FDA inspection or audit of a clinical trial related computer system
FDB3283