This course covers the key concepts of GxP computerised systems validation and compliance, including the key regulatory requirements and effective industry good practice based on GAMP庐5.
Computerised systems validation and compliance is a basic GxP regulatory requirement. Inadequate or inappropriate validation approaches can lead to serious compliance and quality problems. Compliant and validated computerized systems are a prerequisite for effective Data Integrity. This course describes a practical and efficient framework for computerised systems validation and compliance, following current industry good practice, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
Computerised systems validation and compliance is a basic GxP regulatory requirement. Inadequate or inappropriate validation approaches can lead to serious compliance and quality problems. Compliant and validated computerized systems are a prerequisite for effective Data Integrity. This course describes a practical and efficient framework for computerised systems validation and compliance, following current industry good practice, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
