Services Offering
Temperature & Humidity
Mapping
Warehouse
Walk-in Cooler
& Freezer
Refrigeration Equipment Qualification
Refrigerator
Walk-in Cooler
& Freezer
Transport Equipment
Qualification
Truck
Trailer
Lane Study
Full performance
qualitification
Lane profiling
Ensuring the integrity and safety of pharmaceutical products during storage and transportation is critical for regulatory compliance and patient safety. Our expert services are designed to help pharmaceutical companies meet the stringent requirements of Health Canada's GUI-0069 guidelines for environmental control.
Regulatory Compliance & Data Integrity
We understand the importance of seamless regulatory audits. That’s why we offer our clients support during Health Canada audits at no additional fee. Our team will be by your side, providing the necessary documentation and expertise to ensure a smooth and successful audit process.
Support during Health Canada Audits
Compliance Solutions
1. Temperature & Humidity Mapping
Our temperature and humidity mapping services provide thorough assessments of storage and transportation environments to ensure they meet the required conditions. We collect precise data, analyze environmental trends, and identify any potential risks. You can expect fast and convenient services, with a flexible scope to meet your needs. The robustness of our methodology has been demonstrated through numerous
successful audits.​
​
​​​​
2. Refrigeration Equipment Qualification
We offer specialized qualification services for refrigeration equipment, ensuring that your storage units consistently operate within the specified temperature ranges. Our team conducts rigorous testing and validation to verify the performance, reliability, and compliance of your refrigeration systems with GUI-0001 and GUI-0069 guidelines. This includes initial qualification and ongoing requalification to maintain regulatory adherence.
3. Transportation Equipment Qualification
​Our transportation equipment qualification services are designed to ensure that your transport vehicles and containers are capable of maintaining the required environmental conditions during transit. We conduct detailed inspections, testing, and validation of transportation equipment to guarantee compliance with GUI-0069 standards. This ensures that your products remain safe and effective from the point of dispatch to their final destination.
4. Lane Studies
Lane studies are critical for identifying potential environmental risks and ensuring compliance during the transportation of pharmaceutical products. Our experts design and conduct comprehensive lane studies that analyze various transport routes, taking into account factors such as temperature fluctuations, humidity levels, and transit times. This data-driven approach helps in optimizing transport conditions and mitigating any risks associated with environmental variations.