FDA Compliance and Clinical Trial Computer System Validation

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems used in the conduct of clinical trials that are subject to FDA regulations.  This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.  It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

We will discuss the phases within the SDLC, and how these form the basis for any CSV project.  The importance of the sequence of steps will also be covered. Participants will learn about the specific aspects of clinical systems the data required, and how to meet compliance.

• Gain an understanding of the System Development Life Cycle (SDLC) Methodology
• Develop the ability to apply the SDLC when validating computer systems in your organization
• Understand the best practices for maintaining a computer system in a validated state
• Discuss the best practices necessary to ensure all clinical trial data collection and management systems are validated appropriately
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various clinical trial data collection and management systems in your organization and how they are maintained in a validated state
• Learn how to gain information about trends in validation, as the industry progresses and new best practices emerge
• Understand some of the key “pitfalls” to avoid when applying the SDLC methodology

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Clinical Data Collection and Management Systems
• Clinical Trials
• Validation Strategy that will take into account the system risk assessment process
• User Requirements Specification (URS) to include high-level needs in language familiar to the user
• Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
• System Design Specification (SDS) that links design to functional requirements
• Test Planning, including the Development of Scenarios, Cases, and Scripts
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ) (also referred to as User Acceptance Testing (UAT))
• Requirements Traceability Matrix (RTM) that connects the requirements, design, and test elements
• System Acceptance by the user or owner of the system
• System Release Notification once it is put into a production environment
• System Retirement steps to close out the life cycle
• Data Archival to ensure security, integrity, and compliance

• Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
• Learn how to leverage past validation efforts to optimize results
• Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome
• Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay
• Learn how to keep on top of changes to the system over time to ensure it is maintained in a validated state and does not require a complete revalidation due to neglect
• Learn how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business
• Learn how to evaluate business processes to ensure that these are optimized as the system is being developed and/or configured to enable improvements in the efficiency and effectiveness of operations that will save money in the longer run
• Learn how to document all validation work in order to ensure that revisits to the deliverables during subsequent system changes are efficient and do not require extra labor to dig through poorly documented information
• Learn about potential pitfalls to the validation process through real industry examples
• Learn how to avoid and/or mitigate potential pitfalls during the validation process

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists, and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.