Precision is critical to patient safety.
Protect vaccines, biologics and medicines with accurate temperature monitoring across the cold chain.
Temprecord delivers compliant, reliable solutions—from real-time monitoring in controlled environments to trusted data loggers for storage and transport—ensuring product integrity at every stage.
Trusted worldwide since 1993
Accredited to ISO/IEC 17025 standards. Certified under ISO 9001. Recognised by regulated sectors globally.
Key challenges in the Pharmaceutical industry
Ensuring compliance, accuracy and real-time visibility across global supply chains is critical to protecting both products and patient safety. Maintaining continuous, validated and secure temperature records is essential to meet strict regulatory requirements and preserve product efficacy.
Pharmaceutical organisations must manage complex supply chains while minimising the risk of temperature excursions and ensuring consistent environmental control. Challenges include maintaining equipment calibration and data accuracy, enabling real-time monitoring and alerts as well as ensuring data integrity and traceability for audit readiness. Integration with quality systems, along with the cost and impact of product loss and investigations, further increases operational pressure.
Reliable temperature monitoring solutions, like Temprecord’s calibrated data loggers, provide the accuracy, traceability and confidence needed to support compliance and protect product integrity across the cold chain.
Compliance requirements for the Pharmaceutical industry
Meeting strict regulatory standards for temperature control, data integrity and patient safety
Good manufacturing practice (GMP) & environmental control
Maintain validated environmental conditions where temperature and humidity are controlled, monitored and documented throughout production and storage to ensure product quality and compliance.
Good distribution practice (GDP) & cold chain management
Ensure temperature-sensitive pharmaceuticals are stored and transported under defined, validated conditions to preserve product integrity across the supply chain.
Data integrity & 21 CFR Part 11 compliance
Electronic monitoring systems must be validated, secure and compliant with FDA 21 CFR Part 11, providing tamper-proof records, audit trails and controlled user access.
Calibration & traceability
All temperature monitoring devices must be regularly calibrated to traceable national or international standards, with up-to-date certificates maintained for verification and audit purposes.
Validation, qualification & system assurance (IQ/OQ/PQ)
Facilities, equipment and monitoring systems must undergo installation, operational and performance qualification to demonstrate consistent and reliable operation within required limits.
Quality systems, deviation management & training
Organisations must maintain robust SOPs, ensure staff competency and implement effective deviation handling and CAPA processes, including root cause analysis and corrective actions to prevent recurrence.
Pharmaceutical temperature monitoring solutions
Temprecord delivers ISO/IEC 17025 calibrated temperature/ humidity monitoring solutions designed for GMP, GDP & FDA compliance. From manufacturing & storage to distribution, TAD Cloud & G4 data loggers provide accurate, traceable data to maintain product integrity & meet global regulatory requirements.
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