Example of a Part 11 compliant system: "Environmental monitoring system"

This system monitors temperature/humidity in laboratories, thermostatic chambers, stability testers, refrigerators, freezers and storage facilities. With the CISAS series as the operation console and our recorders, loggers, controllers and commercially available PLCs (programmable controllers) as system components, it can be used to configure anything from small-scale standalone systems to medium-scale networked systems.

• Up to 400 system components can be connected, and up to 5,000 measurement points can be configured.
• In addition to the KE series network logger, the KR series graphic recorder and the AL/AH series hybrid recorder can be connected as system components, allowing them to be used in conjunction with on-site operations.
• The CISAS series includes CISAS/V4.
• The CISAS series is a configuration-based package software that can flexibly accommodate changes and expansions to the system.
• We also document and perform validation of computerized systems in accordance with regulatory requirements.