Introduction to Computerized System Validation

Gain the overview and insights you need to successfully validate GxP systems.  We’ll walk you through the life cycle approach from concept and project to operation and eventually retirement.  You’ll learn about the principles and practices to build a foundation of knowledge applicable to any computerized system validation project regardless of scale.  Along the way you’ll also have a chance to put your knowledge to the test with quizzes and assignments.  With multimedia lessons, quizzes, assignments, achievement badges and a certificate of completion we’ll keep you on track and set for success!

The learning objectives of this course are:

1. Define computerized systems, validation and other key terms in this field
2. Understand approaches and strategies to computerized system validation
3. Understand applicable regulations and GxP compliance for your area
4. Provide an overview of the process for each life cycle phase
5. Comprehend the software categories and V-model
   Familiarize yourself with life cycle documentation such as Validation Plans, GxP Assessment, User Requirement Specification, Functional and Configuration Specifications, Risk Assessment, Verification Protocols and Reports,  Traceability Matrices, Configuration Management Plans and more
6. Consider organizational measures and supporting processes for the Operational phase like Change Management, Configuration Management, Incident Management, Business Continuity and others
7. Cover end of life planning for GxP regulated computerized systems from periodic review and data management to developing a retirement plan.