Contact Information

Quality Systems
Integration, LLC

8 Turner Dr.
North Reading, MA 01864

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Welcome to Quality Systems Integration, LLC

Quality Systems Integration, LLC (QSI) in North Reading, MA is a leader in the field of medical device and pharmaceutical/biotechnology consulting. QSI specializes in cGMP quality, engineering and validation technology services.

With more than 20+ years of experience in the industry, we specialize in providing practical and cost-effective solutions to maintain your facility, utility systems, computerized systems, software, and equipment in a validated and cGMP compliant state while maintaining and improving FDA and/or European (ISO) regulatory compliance.

Our experience in the cGMP regulated industries will help you design, implement, and validate the Quality Systems that your facility, utility systems and equipment require to operate in today's
regulated environments. Our business principal is based on the establishment of long-term
relationships with our customers achieved by consistently providing "value added" benefit and maintaining the highest technical quality of validation services with real time relevance to FDA regulations and industry standards.

Our Quality/Engineering Expertise:

  • Aseptic Processing Design
  • Calibration Program Development
  • Clean Room Testing and Certification
  • Environmental Monitoring Program Development
  • Equipment and Facility Design Review
  • Facility Flow Diagram Development
  • FDA Readiness / Presentation
  • GMP Audit
  • GMP Training
  • Maintenance Program Development
  • Program Management
  • SOP Development
  • Vendor / Internal Audits

Our Validation Expertise:

  • Computerized Systems Validation
  • IQ/OQ/PQ Protocol Generation
  • Utilities Validation
  • Facility Validation
  • Process Validation
  • Sterilization Processes Validation
  • Laboratory Systems (LIMS) Validation
  • Process Equipment Validation (IQ/OQ/PQ)