FDA Compliance and Clinical Trial Computer System Validation

Computer system validation (CSV) proves that a system does what it claims and keeps it validated from conception to retirement. This 90-minute webinar explains how to apply the System Development Life Cycle (SDLC) when validating computer systems used in FDA-regulated clinical trials.

You'll walk through each SDLC phase, why the order of steps matters, and how the phases form the basis of any CSV project. The session covers a risk-based validation strategy, user and functional requirements, design specifications, test planning, IQ, OQ and PQ, and the requirements traceability matrix.

It also covers system acceptance, release, retirement and data archival, plus the specific data and compliance needs of clinical data collection and management systems.

• Explain the SDLC methodology and apply it when validating computer systems
• Develop a validation strategy that balances cost and risk
• Validate clinical trial data collection and management systems appropriately
• Maintain computer systems in a validated state over time
• Document CSV work and keep system records current
• Follow validation trends as new best practices emerge
• Avoid key pitfalls when applying the SDLC

• Computer system validation (CSV)
• The System Development Life Cycle (SDLC) methodology
• GxP: Good Manufacturing, Laboratory and Clinical Practice
• Clinical data collection and management systems
• Clinical trials
• A validation strategy based on system risk assessment
• User requirements specification (URS) in the user's language
• Functional requirements specification (FRS) with detailed needs
• System design specification (SDS) linked to functional requirements
• Test planning, including scenarios, cases and scripts
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ), also called user acceptance testing (UAT)
• Requirements traceability matrix (RTM) linking requirements, design and tests
• System acceptance by the user or owner
• System release notification
• System retirement to close the life cycle
• Data archival for security, integrity and compliance

Good planning cuts the time and labor of a validation project, and reusing past validation work helps. This session shows how to test efficiently so deficiencies are found before go-live, keep systems validated through change, manage organizational change, improve business processes, document work clearly and avoid pitfalls seen in real industry examples.

It suits IT, QA and QC, clinical data, lab, automation, compliance, regulatory and CSV professionals, and business users of FDA-regulated systems.

• 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.