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,
• 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:
Director, Business Development/Operations