This specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.
An incident is any unplanned occurrence which prevents (or may prevent) or delays users, the system, an operation, or a service from proceeding with an assigned task. The Incident Management process is intended to provide effective support for unexpected events to users of laboratory, process control, and IT systems.
The CAPA process captures those incidents and failures escalated from the incident management and periodic review processes. These are then tracked from initial occurrence, through impact assessment to resolution and implementation of the correction, recognizing that the control of the resolution and implementation of the correction may be managed by other processes.
The CAPA process also accommodates the situation in which a failure needs both corrective action (to fix a failure) and additional preventive action (to avoid the failure occurring again).
Whenever possible, processes discussed will be aligned on the Quality Management System described by ICH Q10 (Pharmaceutical Quality System) and ICH Q9 (Quality Risk Management).
- How the Operations Phase fits into the Quality Management System
- Operations Phase Processes Lifecycle
- Capture of Operational Control Requirements
- Design of Operational Processes
- Verification of Processes
- Deployment of Processes
- Verification of the Effectiveness of Processes
- Process Relationships
- Risk Management for Operational Processes
- Managers/Directors/Supervisors and Personnel related to:
- Quality Management System
- Quality Assurance
- Quality Control
- Product Development
- Risk Management
- Complaint Handling
- Personnel New to the Regulated Industry
- Training Personnel
- Document Control Personnel
- Regulatory Personnel
Risk Management for Operational Processes http://bit.ly/2UmYyIt