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The above regulations emphasize the completeness, consistency, and accuracy of data throughout its life cycle, and have traceable, clear, synchronized records, original or true copies.


For the management of complex systems such as computers, IT should cover the management content and requirements of account permissions, audit trails, time management, external security, data transmission, data storage and system verification, etc. For the monitoring software itself, from the perspective of IT, At least the system has permission control, time synchronization, audit trail, backup and recovery, data encryption and electronic signature and other functions.


There are three types of data integrity defects that frequently occur in data recording systems: data loss, data errors, and unauthorized access to data.



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* Examples but not limited to the above.


After reading the requirements of the regulations, we now look back at the choice of data monitoring equipment, in order to meet the requirements of the regulations need to consider from many aspects.


First, briefly explain the basic composition and work flow of monitoring equipment:


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The probe 3 detects the data of the monitored device 4, and then transmits it to the recorder 2, the computer, the server 1 through the data transmitted by the recorder to confirm the operation of the entire system, including alarm or transmission interruption, etc., the monitoring system throughout the process of any abnormal, all need to give a record and prompt (alarm), some probes have independent alarm function, But basically limited to sound and light alarm.


1. In terms of technical level and service, the following aspects can be considered:


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2. After-sales service


In my opinion, computer system products, apart from the technical level of their own hardware, the after-sales service level of local manufacturers and suppliers is an important factor that has to be considered. In terms of after-sales service, there are several points that need to be focused on


2.1. Is there a local after-sales service laboratory dedicated to troubleshooting and maintenance of equipment during operation?


2.2. In the process of communication, we should pay attention to the landing of all technologies and guarantees, and consider the actual effects that can be achieved, such as software verification, to check whether GXP verification related to data integrity has been added on the basis of 3Q verification.


2.3 Maintenance personnel for the technical ability, in the selection and purchase of a hardware and software system, the manufacturer or agent is required to provide after-sales engineers related qualifications background information, as a guarantee for later system operation.


In this regard, we have encountered such a problem, the supplier's service attitude is very good, the problem will be immediately repaired, but each maintenance can not give a clear cause of failure and troubleshooting methods. The number of maintenance is found that the engineer sent by the supplier does not understand the equipment itself, and even many problems cannot be solved. Therefore, the ability of suppliers and the service commitment of manufacturers are very important.