[Key Points] Huiju | Hao WenYong: validation of computerized system for API production process control
On April 16, the sixth online seminar of "know the time online" of TianJuShi Group was successfully held. At the meeting, Hao WenYong, an expert in automatic control verification and manager of the verification and test department of the automatic control business department of TianJuShi Group, was invited to introduce in detail the requirements of domestic GMP for computerized system, the typical network architecture of the automatic control system of API process and the key points in the whole life cycle activities, with the theme of "validation of computerized system of API production process control", and from the perspective of a third party The work responsibilities and contents of suppliers and enterprises are introduced, so that the enterprises can understand the key points of control in the project phase, and guarantee the compliance of API automation system in the project phase.
Recognition QR code revisits wonderful classroom
Point 1 what are the general types of process control systems (PCS)?
Process control equipment
Control system integrated with equipment
Control system not integrated with equipment
Point 2 what are the phases of the life cycle of a computerized system?
Point 3 outlines the five steps of risk assessment.
Conduct preliminary risk assessment to determine system impact
Identify functions that affect patient safety, product quality, and data integrity
Conduct functional risk assessment and determine control measures
Implement and confirm appropriate control measures
Review risks and monitor controls