In-Depth Testing of Computer Systems Regulated by FDA
🎤 Carolyn Troiano | 📅 March 25, 2025 | 🕒 11 AM Eastern Time US
Is Your Computer System Testing Ready for FDA Scrutiny?
🚀 Do you understand the critical role of testing in computer system validation? 🚀 Are your validation protocols aligned with FDA and GAMP 5 expectations? 🚀 Want expert insights to ensure compliance and audit readiness? This essential training is designed for professionals involved in computer system validation, compliance, and risk management, including: 👨💻 Information Technology Analysts – Ensure IT systems comply with FDA validation requirements. 🏭 Quality Control (QC) & Quality Assurance (QA) Teams – Strengthen documentation practices for CSV. 🛠 Clinical Data Managers & Scientists – Implement compliance-driven testing strategies. 📊 Compliance & Regulatory Experts – Align validation activities with 21 CFR Part 11 and Part 820. 🔬 Analytical Chemists & Laboratory Managers – Ensure accurate and reliable computer-driven processes. 💡 Automation & Supply Chain Analysts – Develop risk-based approaches for CSV testing. Applicable industries: Pharmaceuticals | Biotech | Medical Devices | Clinical Research | Life Sciences | Regulatory Compliance |
In FDA-regulated industries, computer system validation (CSV) is a critical compliance requirement to ensure that all systems used in GxP environments (GMP, GLC, GCP) are tested, validated, and maintained according to regulatory standards. Non-compliance can lead to severe consequences, including warning letters, fines, and delays in regulatory approval. The FDA mandates that all testing activities—including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—be properly documented and aligned with the System Development Life Cycle (SDLC). Understanding these requirements is essential for passing FDA audits and ensuring your system remains validated throughout its lifecycle. Join Carolyn Troiano, a renowned CSV expert with 30+ years of experience, as she provides a comprehensive guide to testing and validating computer systems to meet FDA expectations.
What You’ll Learn:
✔ Master the Testing Phase of CSV – IQ, OQ, and PQ explained with real-world application.
✔ Ensure Compliance with FDA Expectations – Align validation processes with 21 CFR Part 11, 21 CFR Part 820, and GAMP 5 requirements.
✔ Develop Test Protocols & Scripts – Learn how to write, execute, and document validation tests effectively.
✔ Handle Risk-Based Assessments – Implement strategies to identify system failures and mitigate compliance risks.
✔ Maintain a Validated System – Keep testing a living process throughout the system development life cycle (SDLC).
✔ Prepare for FDA Audits – Ensure all testing activities and documentation are audit-ready.
✔ Leverage Vendor & Contractor Support – Best practices for third-party validation and compliance assurance.
Key Areas Covered:
📌 Definition & Examples of GxP Systems – Understanding FDA-regulated software environments.
📌 Key Premises of FDA Regulatory Oversight – Ensuring compliance with 21 CFR Part 11, Part 820, and GAMP 5 guidelines.
📌 Understanding CSV & the System Development Life Cycle (SDLC) – Best practices for maintaining validation throughout a system’s lifecycle.
📌 Risk Assessment & Testing Strategies – Identifying potential failures and ensuring system robustness.
📌 Software Categorization & Validation Requirements – Criteria for classification under GAMP 5 guidelines.
📌 IQ/OQ/PQ Testing Protocols – Detailed steps for executing each phase of validation.
📌 Validation Plans & Test Documentation – Requirements for a compliant CSV testing program.
📌 Handling Deviations & Test Discrepancies – Addressing errors, failures, and risk mitigation strategies.
📌 Requirements Traceability Matrix (RTM) – Ensuring system validation aligns with user requirements.
📌 Preparing a Testing Summary Report – Best practices for documenting test outcomes for regulatory review.
📌 System Acceptance & Notification – How to confirm and communicate successful validation.
📌 Standard Operating Procedures (SOPs) & Training – Establishing guidelines for ongoing validation compliance.
📌 Conducting Periodic Reviews – Ensuring long-term compliance and readiness for FDA audits.
