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Are You TGA Audit-Ready, Right Now?
testo Saveris 1 is the automated GxP environmental monitoring system that puts Australian pharmaceutical manufacturers permanently audit-ready, continuously tracking temperature, humidity, and CO₂ across labs, cold rooms, and storage areas, with tamper-proof reporting and 24/7 excursion alerts.
The Challenge
Manual compliance is no longer good enough
TGA's updated GMP framework (PIC/S PE009-16, June 2024) and the ICH E6(R3) transition deadline of January 2027 are raising the documentation bar for pharmaceutical environmental monitoring in Australia. Is your lab and storage monitoring system keeping up?
Manual Logs Fail Audits
Spreadsheets and paper logs are one of the causes of TGA non-compliance findings, incomplete records, transcription errors, and gaps that inspectors find immediately.
Temperature drifts Go Undetected
Temperature deviations that occur overnight or on weekends aren't caught until the next morning, by which time a batch may be compromised, and product loss is unavoidable.
Compliance is Consuming Your QA Team
QA staff spend hours each week on manual log rounds, chasing down records, and compiling reports for inspections, time that could be spent on higher-value work that actually moves the needle.
The Solution
Stop managing compliance.
Start proving it, automatically.
testo Saveris 1 is a fully automated environmental monitoring system designed for GxP-regulated facilities. It continuously records every parameter, generates compliant reports on demand, and alerts your team before thresholds are ever breached.
Compliant with 21 CFR Part 11, EU GMP Annex 11, and TGA PIC/S GMP, no spreadsheets, no gaps, no excuses at audit.
Get notified before critical thresholds are breached, not after. 24/7 coverage with SMS, email, and app alerts.
Modular architecture scales with your facility; add sensors, zones, and locations without revalidation or infrastructure replacement.
Generate inspection-ready reports in minutes, not hours. Your team focuses on higher-value work while Saveris 1 handles the documentation.
Key Capabilities
Everything your QA team needs. Nothing they don't.
Built specifically for GxP-regulated environments, testo Saveris 1 combines hardware reliability with software-driven compliance intelligence.
Eliminate Manual Documentation Risk
testo Saveris 1 continuously logs every parameter, temperature, humidity, and CO₂ and generates GxP-compliant reports on demand. The tamper-proof audit trail is always complete, always current, and always inspection-ready.
Catch Drifts Before They Become Incidents
Pre-alarm early deviation alerts notify your team before critical thresholds are breached, not after. Configure escalation paths by zone, time of day, and severity level so the right person is always notified.
Free Your QA Team from Manual Monitoring
testo Saveris 1 automates routine log rounds, data collection, and compliance report generation across labs, cold rooms, stability chambers, and storage areas, so your QA team can focus on quality outcomes, not paperwork.
Scale Without Starting Over
testo Saveris 1's modular architecture grows with your operation. Add sensors, new locations, and parameters without replacing your infrastructure or revalidating from scratch. One system, validated once, for your entire facility.
Webinar:
How to address monitoring challenges in Biotech.
Join our live session covering how to efficiently and compliantly monitor temperature, humidity, pressure, and other environmental parameters in highly regulated biotech environments. This includes understanding why monitoring matters in biotech, navigating key industry and regulatory challenges, and recognising the impact of poor monitoring on product quality and compliance.
Explore our latest resources
Cost Efficiency in Pharmaceutical Monitoring Systems
This whitepaper explores how digital environmental monitoring systems, such as testo Saveris 1. Download our whitepaper now.
21 CFR Part 11 Compliance
On the safe side: Fulfilling the FDA’S 21 CFR Part 11 requirements using testo Saveris Pharma Solutions. Download now.
Orthocell - A Testo reference story
Expanding Orthocell benefits from an intuitive environmental monitoring system. Read the reference story now.
See how Saveris 1 protects your biorepository
Talk to our Australian life sciences monitoring team. We'll walk you through how Saveris 1 fits your specific storage environment: your units, your compliance requirements, and your collection.
📞 Speak with an Australian biobanking compliance specialist
🖥️ See a live demonstration of Saveris 1 alerts and reporting
📄 Receive a site-specific monitoring assessment
FAQ
Common questions about Saveris 1
Everything your QA team needs to know about GxP environmental monitoring compliance in Australia.
Yes. testo Saveris 1 is fully compliant with TGA PIC/S GMP PE009-16, 21 CFR Part 11, and EU GMP Annex 11. It maintains a tamper-proof, continuous audit trail across all monitored labs, cold rooms, and storage areas, meeting the documentation standards required by TGA inspections.
Saveris 1 monitors the environmental conditions within specific rooms and zones, including laboratories, cold rooms, stability chambers, clean rooms, and pharmaceutical storage areas. It continuously tracks temperature, humidity, CO₂, and other parameters critical to GxP compliance.
Saveris 1 generates GxP-compliant reports on demand, maintains a continuous tamper-proof audit trail, and eliminates the manual documentation gaps that are the most common cause of TGA non-compliance findings. Your facility remains permanently audit-ready without additional team effort.
Yes. Saveris 1 features configurable pre-alarm early deviation alerts that notify your team before critical thresholds are breached, via SMS, email, and in-app notifications. Escalation paths can be configured by zone, time of day, and severity level to ensure the right person is always notified in time to act.
Yes. Saveris 1's modular architecture allows you to add sensors, monitoring zones, and new locations without replacing your existing infrastructure or revalidating from scratch. One validated system can scale across your entire pharmaceutical facility as your operation grows.