This seminar will explore the best practices and strategic approach for evaluating computer systems used in the conduct of clinical trials and determining the level of compliance, based on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will also walk through the entire set of essential clinical trial files that must be maintained before, during and after completion of the trial in the Trial Master File (TMF). This part of the discussion will also delve into the use of electronic Trial Master File (eTMF) systems and the pros and cons of doing so.
Finally, we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials. These are extremely valuable assets for any company doing this type of work, and best efforts are necessary to ensure data is maintained in a state of integrity throughout its lifecycle.
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