155 West Street, Suite 1  Wilmington, MA 01887          (508) 958-2857          info@qsiglobal.net


Quality Systems Integration, LLC (QSI), located

north of Boston, is a leader in the field of medical

device and pharmaceutical/biotechnology consulting.

QSI specializes in CGMP quality, engineering, and

validation technology services.

Our Demonstrated Areas of Expertise:

     • Commissioning/Qualification/Validation of Equipment, Process, Utilities,

        Computers (CSV)

     • Revalidation (Requalification) Program Development and Management

     • Quality and QA Validation

     • Metrology/Calibration Program Development and Maintenance

     • FDA Remediation

     • Document Management Programs (SOPs, CAPAs, Internal audits, External audits,


Our recent Work with Clients:

     • Lead commissioning, qualification, and validation firm during the design and

        construction of a new manufacturing facility. Worked through equipment design,

        electronic software assessment, FAT/SAT, commissioning, IQ/OQ/PQ and final


     • Develop qualification/validation strategies and crafting Validation Master Plans

        (VMPs) and Validation Project Plans (VPPs).

     • QA Validation oversight of validation project documents.

     • Execution of scheduled Vendor Audits and Mock FDA Audits

     • Development of Remediation Programs to help our clients address: Discrepancies,

        Nonconformances, CAPAs, SOP review and Internal Audits.

     • Develop and execute client periodic Revalidation/Requalification Programs.

To Learn More About our Services, Contact:

Dave Roberts

Director, Business Development/Operations