CGMP Controlled Room Temperature (CRT) Warehouse Storage
Quality Systems Integration, LLC (QSI), located north of Boston, is a leader in the field of medical device and pharmaceutical/biotechnology consulting. QSI 3PL Plus delivers quality, security, and traceability.
Founded by Shaun McCormack in 2001, we specialize in providing practical and cost-effective
solutions to warehousing pharmaceutical and medical device products and raw materials in
a CGMP compliant state while maintaining and improving FDA and/or European (ISO)
regulatory compliance.
As subject matter experts in the handling of temperature-sensitive products, QSI maintains GMP validated controlled temperature storage as a core competency. QSI offers the following environments for clinical trial material storage, drug storage, vaccine storage and medical device storage:
Our Demonstrated Areas of Expertise:
- Validated temperature monitoring system for varying storage environment(s)
- Validated GMP warehouse management system
- Planned redundancy of critical systems to ensure business continuity and control
- Infrastructure for rapid implementation or expansion
- Compliant receipt, storage, rotation, sampling and distribution solutions
- Controlled access and state of the art alarm system
Warehouse Specifications:
• Controlled Room Temperature (CRT): +20°C to +25°C
• Ambient: +15°C to +30°C
• Fully validated equipment and environment
• Secure storage - 24/7 monitoring with controlled access
• Validated temperature monitoring system
• Validated GMP warehouse/inventory management system
• Infrastructure for rapid implementation or expansion
• 4,800 sq. ft. of CRT (20 – 25 ℃ ) space - 330 pallet positions
• Cold storage capability
• 2 – 8 ℃ storage 50 cubic ft
• -20 ℃ storage 25 cubic ft
• -80 ℃ storage 25 cubic ft
• ICH Stability storage 75 cubic ft
Off-site cGMP storage of your products allows you to free up precious real estate while remaining compliant to regulations and internal Standard Operating Procedures. QSI knows the importance of your product(s) and that a patient’s life depends on how we handle it.
To Learn More About Our Services, Contact: