The testo Saveris solution.
Testo Saveris supports you in four ways. The environmental monitoring system records and analyzes your critical environmental data, alerts you immediately if limit values are violated and can help you optimize your processes. For this, the all-in-one solution uses three performance-related components: sensors, software and services.
Hardware
Thanks to more than 60 years of experience in the manufacture of measuring solutions and sensors, Testo has all the measuring instruments you need to monitor environmental parameters. These include data loggers for automatic recording of readings and alerts.
Software
The testo Saveris software meets the most stringent requirements for contemporary measurement data management. The globally accessible and audit-proof platform enables comprehensive analysis and evaluation of all recorded measurement parameters – with the aid of flexible alarm systems, various logging functions and a wide variety of database hosting options.
Services
Our specially trained service team accompanies you through all process steps in a customer-oriented and systematic manner – from the planning, mapping, site acceptance test (SAT), documentation and system qualification through to service and support.
When designing a temperature monitoring system for pharmaceutical cold chain compliance with FDA requirements, consider the following top 10 requirements:
- Regulatory Compliance: Ensure the system adheres to FDA guidelines, including 21 CFR Part 11 for electronic records and signatures.
- Real-time Monitoring: Implement continuous temperature monitoring to detect deviations promptly, with alerts for out-of-range conditions.
- Data Integrity: Ensure data accuracy, reliability, and security through validated systems that prevent unauthorized access and alterations.
- Calibration and Validation: Regularly calibrate and validate sensors to ensure accuracy. Maintain records of calibration and validation activities.
- Temperature Range Specification: Support the specific temperature ranges required for different pharmaceuticals (e.g., refrigerated, frozen).
- Automated Reporting: Generate automated reports for compliance audits, detailing temperature history and deviations.
- User-Friendly Interface: Provide an intuitive interface for easy operation and monitoring by personnel with varying technical skills.
- Alarm and Notification Systems: Include configurable alerts (e.g., SMS, email) for immediate notification of temperature excursions.
- Data Backup and Recovery: Implement robust data backup solutions to prevent loss of critical monitoring data and ensure quick recovery.
- Training and Support: Offer comprehensive training for users and ongoing technical support to address issues and maintain compliance.
These requirements help ensure the integrity of the cold chain for pharmaceuticals, safeguarding product efficacy and patient safety.