Testing for Compliant Computer Systems for FDA
Effective and compliant computer system validation is critical to any pharmaceutical or F DA-regulated organization . Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience. In this webinar expert speaker Carolyn Troiano , will discuss the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements . Speaker will also discuss the guidance for maintaining the system in a validated state and assessing the level of any testing tha0t might be required post-validation to ensure that compliance Session Highlights: Determine the category of your system, based on GAMP 5 from ISPE Determine the ...