Compliance Services - ROTRO Instruments

🔬 Calibration Services

Our CNAS L12399 accredited laboratory provides traceable calibration for temperature, humidity, CO₂, pressure, and dew point instruments. All certificates are internationally recognized under ILAC-MRA.

Temperature sensors & loggers
Humidity & dew point transmitters
CO₂ probes & monitors
Pressure transmitters
On-site calibration available

✅ Qualification Services

GxP-compliant qualification and validation for pharmaceutical and life science facilities:

Autoclave / sterilizer validation
Freeze dryer thermal mapping
HVAC & cleanroom qualification
Cold storage & warehouse mapping
IQ/OQ/PQ documentation

⚙️ Operations Support

We design, implement and maintain Continuous Monitoring Systems (CMS) for regulated environments:

System design & architecture
Hardware installation & commissioning
Software configuration (viewLinc)
Annual maintenance contracts
24/7 emergency support

📋 Consulting

Expert guidance for regulatory compliance and quality systems:

GMP / GxP compliance gap analysis
Data integrity assessment (ALCOA+)
21 CFR Part 11 readiness
EU GMP Annex 1 / Annex 11
Audit preparation & support

Need compliance support?

Our expert team is ready to assist with your specific requirements