Example of a Part 11 compliant system: "Pharmaceutical warehouse temperature control system"

The pharmaceutical warehouse consists of a warehouse for storing raw materials, intermediates, and APIs, as well as a warehouse for distributing shipment products.
Both are large warehouses with a variety of systems including fixed racks, movable racks, and automated racks. The MD8000 Series wireless loggers are suitable for managing the temperature of stored items in movable and automated racks.

• It is wireless and can be battery-powered for long periods of time, making it ideal for mobile rack or automated rack warehouses.
• Even in an existing warehouse, the system can be built inexpensively without the need for wiring work.
• The logger with integrated sensor and transmitter can be taken back to the factory for calibration. It reduces the cost of periodic calibration work at high warehouse locations and loop calibration during OQ.
• application software with security functions compatible with Part 11 is also available, and can be applied to Part 11 and ER/ES guidelines.
• We also document and perform validation of computerized systems in accordance with regulatory requirements.