Services
Digital Calibration & Validation Solutions
A fully automated, paperless calibration system that replaces slow, error-prone paperwork — faster turnaround, absolute data integrity, and every certificate a click away.
- 21 CFR Part 11 Compliant
- Paperless Workflow
- USFDA / WHO / EU GMP
Digital platform
Paperless by design, compliant by default
Auravea is revolutionising traditional metrology by replacing slow, error-prone paperwork with a fully automated, paperless calibration system. By eliminating manual documentation, our modern approach accelerates turnaround times and ensures absolute data integrity. Clients benefit from drastically reduced equipment downtime, faster service delivery, and instant, secure digital access to all calibration certificates and mapping reports via a cloud-based portal.
At the core of our operation is a proprietary, 21 CFR Part 11 compliant software platform designed to meet the strictest global regulatory standards. This system completely automates the calibration and thermal mapping process, utilizing built-in technical validations to catch and eliminate human data entry mistakes. By pairing advanced software automation with rigorous compliance frameworks, Auravea delivers flawless, audit-ready documentation that guarantees peace of mind for high-stakes industries.
Key highlights
What the paperless system changes
Five outcomes the platform delivers on every calibration and every mapping study.
Zero Manual Errors
Built-in technical validation checks flag and eliminate human entry mistakes.
Audit-Ready Accessibility
Retrieve your secure, digitally signed certificates instantly from anywhere.
Accelerated Timelines
Automation removes administrative bottlenecks, getting your equipment back online faster.
Investigation Support
Availability of all associated data in a defined report format supports failure investigations.
Regulatory Peace of Mind
Fully compliant with global electronic record and signature standards.
Calibration & validation
Precision calibration, traceable to international standards
Auravea delivers comprehensive calibration, equipment qualification, and facility validation solutions tailored for the pharmaceutical, food, beverage, and FMCG sectors. Our technical expertise spans precision calibration across thermal, electrical, mechanical, and pneumatic operations, ensuring that your critical process instruments maintain the exact tolerances required for product quality. Every service we provide is backed by internationally traceable measurement standards and meticulously calculated uncertainty budgets, guaranteeing absolute accuracy and technical integrity.
Our capabilities extend to full-scale equipment qualification and specialized industrial testing designed to keep your facilities compliant and operational. We conduct precise thermal mapping for critical storage equipment and areas, comprehensive HVAC validations, and rigorous steam quality testing to meet stringent regulatory requirements.
Thermal Calibration Services (Temperature & RH)
Specialized thermal calibration covering a wide range of critical instruments and controlled environments. Our capabilities include the precise calibration of sensors such as thermocouples, RTDs, and thermometers, alongside data loggers, environmental chambers, ovens, and autoclaves. We also qualify high-stakes process equipment including lyophilizers, depyrogenation tunnels, incubators, refrigerators, freezers, stability chambers, and humidity indicators. Every calibration is executed to the highest standards, delivering fully compliant measurement uncertainty statements that effortlessly satisfy rigorous global regulatory norms.
Mechanical Calibration Services
Expert mechanical calibration across a diverse spectrum of precision measuring instruments to guarantee operational accuracy and regulatory alignment. Our capabilities encompass advanced pressure metrology, including pressure gauges, digital pressure indicators, pressure transmitters, multimeters, clamp meters, lux meters, insulation testers and process calibrators.
Equipment qualification
Thermal Qualification
For highly regulated industries like pharmaceuticals, biotechnology, and medical device manufacturing, we deliver equipment qualification services strictly aligned with global cGMP, GLP, and regulatory standards. We ensure your critical systems are fully validated and completely audit-ready.
Auravea provides full-lifecycle validation for temperature-controlled equipment, including incubators, refrigerators, freezers, stability chambers, ovens, autoclaves, and environmental chambers. We execute comprehensive Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, delivering robust, documented evidence and summary reports that guarantee regulatory compliance.
Controlled Environments
Full-scale mapping for warehouses, cleanrooms, cold rooms, stability storage and transport containers.
Compliant Sensor Placement
Grid-based sensor layouts deployed strictly per ISPE and PDA guidelines.
Continuous Monitoring
Uninterrupted data logging across specified study durations.
Gradient Mapping
Precise identification of hot spots, cold spots and fluctuations.
Actionable Reporting
Comprehensive assessments and recommendations.
Specialized testing
Steam quality and smoke studies
Qualification documentation structured for regulatory audit compliance, including USFDA, WHO, and EU GMP requirements.
Pure Steam Quality Test
Pure Steam quality testing for pharmaceutical and biotech applications, including:
Steam Purity
Non-condensable gases, steam dryness, and superheat testing per EN 285 and HTM 2010 standards.
Pure Steam Testing
Chemical and microbiological analysis.
Autoclave Performance
In-depth thermal distribution and heat penetration studies to qualify the efficacy of your active sterilization cycles.
3D / 4D Smoke Studies
Smoke studies with three- and four-dimensional coverage for isolators, RABS, UDFs and aseptic areas.
Risk-Based Protocols
Designing protocols as per risk assessment of the manufacturing process to comply with current regulatory expectations.
Multi-Dimensional Coverage
Coverage of each operational step to demonstrate the sterility assurance level.
First Air Assurance
Ensure the First Air concept during machine assembly, component transfer and the handling of interventions (inherent and corrective).
Ready to go paperless?
Calibration, qualification or a full facility validation — our technical team will scope a fully compliant, audit-ready programme with you.