This course is available for onsite or custom training. Please contact us if you are interested in scheduling this class for your group.
Course Description:
Your team is a group of professionals in the world of computers and software. You know what it takes to implement a quality product. But you've heard that your next big project will require validation! What now? Does this mean more work? More deliverables?
This course will answer these questions for your team.
After a brief walkthrough of the FDA regulations for computer system validation, we'll get right to the heart of the matter. We'll show team members how computer system validation (CSV) can fit into your group's existing software life cycle (SDLC or SALC). Then, everyone gets hands-on practice producing key CSV deliverables, such as Requirements, Test Plans, Validation Protocols (IQ, OQ, PQ), Test Summaries, and Trace Matrices. After two days, your team will return to your work ready to take on that validation project together, and with confidence!
- The overall computer system validation framework and deliverables
- Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC)
- Hands-on practice creating key validation deliverables, including Requirements, Test Plan, Validation Tests (IQ, OQ, PQ), and Test Summary
- Best practices for validation test execution, documentation, and error handling
- Introduction to the key FDA regulations and guidance documents you need to know
- Overview of most common FDA warnings regarding software validation
Teams of IT, QA, & Business Professionals who need to:
- Create CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), test plans and test reports.
- Participate on computer system projects requiring validation.
- Understand the process of computer system validation.
- Understand the FDA and international regulatory requirements for computer systems.
Course Binder
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