Example of a Part 11 compliant system: "Centralized management system for temperature data of cool storage cabinets"

This is a centralized management system that uses a graphic recorder KR to monitor alarms, monitor, and data logging such as temperatures for pharmaceutical and medical refrigerators and storage cabinets that are installed in various locations, and then electronically records and manages the temperature and other data collected by the graphic recorder KR using the electronic record centralized management package CISAS/ER.

• Electronic record management can be performed in accordance with Part 11 and ER/ES guidelines.
• The graphic recorder allows monitoring using trend display and list display, and can send email notification when an alarm occurs.
• By using an M2M router or similar to extend Ethernet, you can build a remote monitoring system at low cost.
• Measurement data can be saved in the graphic recorder. Saved data is electronically recorded and managed in the database of the CISAS/ER server, and can be viewed on the CISAS/ER client, and daily and monthly reports can be output.
• By adding the CISAS/V4 package software to the computer, individual monitoring and alarm monitoring using a graphic recorder can be expanded into a centralized monitoring system using a computer.
• We also document and perform validation of computerized systems in accordance with regulatory requirements.