Understanding Computer System Validation (CSV)

Computer Systems Validation (CSV) is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable. The system has to be relied upon to:

• produce data accurately and consistently
• create an indelible electronic data trail that is transparent, traceable and tamper-proof
• store electronic data records in a way that is safe, secure and can stand the test of time

Computerised system validation and compliance is a regulatory requirement. Inadequate or inappropriate validation can lead to serious non-compliance and quality problems. Compliant and validated computer systems are a prerequisite for effective data integrity.

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5).

This course will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.