Computer System Validation (CSV) is a critical process in regulated industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. It ensures that computer systems operate consistently, reliably, and in compliance with regulatory requirements. Gap and risk analysis are essential components of CSV, helping organizations identify deficiencies, assess risks, and implement corrective actions to ensure system integrity and compliance.
A tailored approach in CSV provides a flexible, efficient, and risk-based framework for validating computerized systems. It ensures that validation efforts are proportionate to the system's impact, aligned with regulatory requirements, and integrated with business processes. By adopting a tailored approach, organizations can achieve compliance, reduce costs, and improve operational efficiency while maintaining the integrity and reliability of their systems. Tools like AUXO further enhance this approach by providing automation, standardization, and risk management capabilities, making the validation process more robust and manageable.