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[Key Points] Huiju | Hao WenYong: validation of computerized system for API production process control


[Key Points] Huiju | Hao WenYong: validation of computerized system for API production process control

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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?


Concept stage

Project phase

Operation stage

retirement phase


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