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Pharma Validation & Qualification Services
Reliable validation for critical systems.
ENVIRONMENTAL MONITORING FOR REGULATED ENVIRONMENTS
Comprehensive Qualification & Validation
Testo North America provides qualification and validation services to support facilities, equipment, and supporting systems used in regulated pharmaceutical, biotechnology, contract manufacturing, and regulated logistics environments. Our services are designed to help organizations demonstrate that critical systems are fit for their intended use while supporting reliable, efficient operations.
We work with clients to qualify facilities and equipment, perform temperature mapping studies, and execute targeted computer system validation activities related to Testo Saveris environmental monitoring and data collection. All activities are performed using a risk-based approach aligned with recognized industry guidance and regulatory expectations.
Facilities & Equipment Qualification
Qualification of controlled spaces, warehouses, rooms, utilities, and equipment
Design, Installation, operational, and performance qualification (DQ/IQ/OQ/PQ), as applicable
Temperature mapping of rooms, chambers, and controlled environments
Computer System Validation (CSV) for Pharma
Validation of Testo Saveris environmental monitoring system (EMS)
Review of data integrity, alarms, and system configuration
Risk-based validation focused on systems supporting environmental control
Our Risk-Based Validation Approach for Pharma Compliance
Testo North America applies a structured, risk-based methodology grounded in recognized industry standards, including ASTM E2500-13 and applicable ISPE guidance. Our approach focuses on systems and functions that directly impact product quality and regulatory compliance while avoiding unnecessary testing of low-risk elements.
Activities are planned and executed in coordination with site operations to minimize disruption and generate documentation suitable for quality review and regulatory inspection.
Audit-Ready Deliverables for Pharma Validation
Deliverables are structured to support ongoing operational use and internal quality requirements. Typical deliverables may include:
Approved qualification or validation protocols
Executed test records
and raw data
Deviation documentation
and resolution
Summary reports supporting inspection readiness
Networked System Validation
Our U.S.-based service team provides comprehensive validation services for the testo Saveris 1 monitoring system, ensuring your solution meets GxP and regulatory requirements from day one.