Quality Systems Integration
BioTech/Drugs - Wilmington, MA, US
Quality Systems Integration Employees
Quality Systems Integration Details
QSI is composed of three divisions: - Consulting: Specializes in providing practical and cost-effective solutions to design, document, and validate your facility, utility systems, computerized systems, software, and equipment in a CGMP compliant state while maintaining and improving FDA and/or European (ISO) regulatory compliance.- Testing & Certification: Cleanroom and controlled environment testing and certification. Our T&C services include (but are not limited to) HEPA Filters, Cleanrooms, Biosafety Cabinets, Laminar Flow Hoods, Fume Hoods, Non-Viable Sampling, and VHP Decontaminations- cGMP CRT Storage: GMP validated controlled temperature storage for clinical trial material storage, drug storage, vaccine storage andmedical device storage. Our facility and chambers have been validated to cover the most widely used temperature ranges, in a secure location with continuous monitoring.
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