Validation of your Testo Saveris 2 system according to GAMP 5 – we support you from planning and execution through to complete, gap-free documentation. This makes your monitoring system secure, audit-ready and compliant with all relevant standards – with practical templates, clear process flowcharts and expert consulting from a single source.
Do you have a doctor's office, pharmacy, diagnostic laboratory, pharmaceutical warehouse, or do you offer contract logistics for the food industry?
Do you have an audit finding because your system is not validated?
After contacting the manufacturer, were you told that the system cannot be validated?
We offer support with installation and prepare templates for validation:
- User requirement specifiation (URS)
- Validation plan
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Validation report
- Procedural instructions for regular operation
- Desaster and recovery plan
The Testo Saveris 2 Wi-Fi-Based Monitoring System
Testo Saveris 2 is a wireless data logger system for continuous monitoring of temperature and humidity values in storage and work rooms. The loggers record measurements at adjustable intervals, store them locally in a ring buffer and automatically transfer them via Wi‑Fi to the Testo cloud as an online data repository.
The measurement data can be viewed, analysed and exported as PDF/CSV reports from any location using a browser or mobile devices. Alarm functions notify users of limit value violations by email or optionally by SMS. Parts of the system are tested according to EN 12830 and use protection classes such as IP65; battery lifetimes of up to 12 months are possible.
Typical applications
Testo Saveris 2 is used for temperature and humidity monitoring in storage, refrigeration and work rooms, for example in the food industry, the pharma/healthcare sector and in laboratories.
Typical applications include monitoring refrigerators and freezers for medicines and vaccines, temperature monitoring in food storage, production and order-picking areas, as well as indoor climate monitoring in facility management. By connecting probes (e.g. NTC temperature probes, door contacts), it is also possible to monitor door openings on cooling devices or critical measurement points in climate chambers and incubators.
The system is also suitable for museums, archives or sensitive storage zones where constant environmental conditions must be demonstrably maintained.
Quality management requirements
In quality management, Saveris 2 supports proof of compliance with temperature and humidity specifications in line with food and pharmaceutical regulations (e.g. HACCP concept, GDP/GMP-related requirements).
Relevant requirements include a validatable, tamper-proof measurement and documentation system, gap-free recording with ring memory and cloud backup, and secure user and rights management for cloud access. For audits, limit values, alarm strategies and measurement intervals must be defined, documented and regularly reviewed; automatic reports (PDF/CSV) serve as evidence in QM systems according to ISO 9001 or ISO 13485.
In addition, regular calibration of probes, documentation of alarms and corrective actions, and – depending on the sector – consideration of standards such as EN 12830 for temperature loggers are required.
