GMP verification service

GMP verification serviceFeatures and advantages

The software adopts modular design, which can flexibly adjust the front-end interface according to user needs and accept personalized function customization

Custom reports, with multiple built-in report templates and the ability to create new templates based on user submitted paper reports and automatically generate them

Software localization design, multiple optimizations of the logical order of various functional menus and the display effect of front-end pages, achieving ready to use after installation without learning barriers

In line with local operation habits, all data and charts formed can be shared, sent, saved, and edited with just one click through WeChat, DingTalk, QQ, and other methods

The system can set different alarm templates and assign them to different measurement points

Automatically generate PDF reports and serial numbers, and support encryption function

Using the device tag number as the management unit, multiple SN numbers can be assigned sequentially, and SN numbers can be reused (replacing calibration)

The replacement device can continuously display the data from the old recorder on the historical data curve, which can indicate the replacement time and SN number

Add 'next calibration time' when adding devices and add 'calibration expiration' reminder alarm type in alarm settings

The system adopts a buyout system, with no restrictions on the number of accounts, terminals, or software functions

Ze Da Instrument GMP Verification ServiceMainly includes the following services:

Verification Mapping of Temperature and Humidity Distribution

The overall goal of temperature and humidity verification is to verify whether the product storage and transportation conditions of pharmaceutical and medical device production and operation enterprises comply with regulations, and are subject to the supervision of relevant provisions in Appendix 5 of the Chinese GSP regulations and Appendix 2 of the Chinese GMP regulations. Especially for the facilities and equipment equipped by enterprises engaged in the production and operation of refrigerated and frozen drugs/medical devices, it is necessary to develop relevant SOP operating procedures based on the conclusions obtained from verification to ensure that the corresponding operating procedures can ensure that the temperature and humidity of drugs and medical devices are always controlled within the specified range during storage and transportation, in order to ensure quality and safety.

Computerized System Validation

Using our GxP expertise and understanding of China's GMP and major international pharmaceutical quality management systems, combined with the actual situation of Chinese GMP enterprises, we have specially designed a high-quality computerized system verification service system with strong compliance, efficient processes, and strong operability to help our users shorten project implementation time and quickly put EaseFactor system into operation.

Facility equipment 3Q/4Q verification

EaseCalib Calibration Service

Ze Da Instrument provides multiple calibration options for data recorders and other types of instruments in environmental monitoring systems to ensure measurement accuracy. You can choose laboratory calibration, on-site comparison, or probe replacement services, and leave the rest to our experts. All calibration options come with a third-party CNAS calibration certificate, which is suitable for internal and external audits. Comply with the requirements of Chinese GMP and other GxP regulatory rules,