Part11 compliant monitoring for clean rooms and laboratories

Delphin Technology AG: The operation of clean rooms, pharmacies and laboratories is subject to regulations on the monitoring of temperatures, pressures and particle counts where the FDA 21 CFR part11 guidelines generally apply. Delphin is a single source supplier of hardware and software for such applications.

In comparison to other systems available on the market, our monitoring solutions can be adapted exactly to your individual requirements. Such scalability is available for both hardware and software products. Individual requirements can be incorporated even when designing the user-interface. The user-friendliness of trend graphs enables users to quickly and easily access current and historical measurement data. The flexible and versatile applications can be fully validated.

Our system offers the following functions:

• High data security: To guarantee data security, Delphin-based systems simultaneously record acquired measurement data in three separate ways.
• Continuous recording: Each measurement value is recorded, stored and archived. To reduce data volumes, data tolerances, averaging and clock cycles can be defined as required for specific channels.
• Traceability: Each measurement value in the data logger is given a time and date stamp. The data is only then transmitted to network participants (PC/server).
• Manipulation safe: All measurement data, files and databases are recorded using a binary-coded procedure.
• Comprehensive system of alarm management: Highly versatile alarm conditions can be defined: limit values, conditions or system monitoring.
• Access protected: Hardware and software can be fully protected against unauthorized access. Invalid password input is monitored with definable limits according to user details.
• Detailed documentation and validation for the entire application: Generation of all documentation required for validation: plan, risk analysis, DQ, IQ, OQ, PQ.
• Audit trail: Recording of all system relevant user actions to a centralized audit trail.
• Digital signatures: Confirmation and acknowledgment of changes and user input via a system of user names and passwords.
• Reporting: Automated or manual reporting with measurement data output for required time periods.
• Version management: Manage your applications with easy to follow options for version management.

As a Delphin customer you benefit from our full-range of services such as training, system installation, device calibration and a free-of-charge hotline. We will be pleased to help you and are looking forward to your call!