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Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. Testing is a key aspect of computer system implementation, validation and all activities related to the system development life cycle (SDLC). As such, there are specific deliverables and key tasks that must be completed in accordance with FDA requirements. The best practices associated with testing methodologies used in the FDA-regulated arena, can be used to develop a
standard and consistent approach within a company. Join this session with expert speaker Carolyn Troiano to learn all about preparing your system validation documentation for an FDA audit of your company's computer systems.
Key Learning Objectives
- The testing component of computer system validation (CSV) work that is aligned with the system development life cycle (SDLC) methodology
- The FDA requirements for documentation of all testing activities
- How to write a test protocol for each phase of testing, i.e. IQ, OQ, and PQ)
- How to develop test scripts and acceptance criteria
- How to identify test discrepancies and distinguish the type: test script errors, tester errors, and system errors
- How to document all testing and the summary reports
- How to maintain the system in a validated state, and keep testing as a �living' exercise that runs through the system life cycle
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Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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, developing and executing compliance strategies and programs.
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