Computer System Validation (CSV) or Software Validation is a mandatory regulation from the “Health Canada”, “Food and Drug Administration” (FDA) and the “European Union” (EU) to ensure all the computerized systems or automated data processing systems used in health care industry (Pharma/Medical Devices/Logistics/Warehouse) shall be validated for its intended use according to established pre-defined protocols developed and approved before production use.
The introduction to Computer System Validation module provides the basics of Software Validation, its regulations throughout the life cycle of any computerized systems and the foundation knowledge required to workday- to-day in any regulated health care industry.
This module focuses on the regulations and standards behind CSV, recommendations, and best practices for CSV, understanding the role of GAMP®5 (GAMP5), and the competence required for a validation team. This module includes comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.
Professionals working in the healthcare, clinical trial, biopharmaceutical, and medical device sectors in areas of:
