Quality Systems Integration in North Reading, MA offers a full-range of validation, engineering and quality systems services for cGMP/GXP processes and facilities. We have a wide variety of contract validation professionals to assist in all areas of quality compliance.
Shaun P. McCormack the company’s owner started his career in the medical device industry focusing in the area of Quality and Validation Engineering. After he honed his Medical Device Regulations background he moved to a small somatic cell therapy company that was eventually absorbed by a large pharmaceutical company. This allowed Mr. McCormack the opportunity to work with FDA on facility design, process validation and quality documentation for cell therapy and pharmaceutical products. His work, at this particular company, culminated with the hosting and management of the company’s first BLA inspection and subsequent licensing. Shaun saw the challenge in today’s industry with trying to balance what is required by regulations with industry standards and decided to work with companies to define standards and work to maintain the systems required to operate in today’s regulated industry.
QSI will customize project resources based on the project scope and client needs. Each of our contractors has anywhere from 2-10+ years of hands-on experience in facility design and construction, utility systems, process equipment, process qualification as well as process validation, computer system validation, SOP development, system and vendor auditing and validation of equipment used in the health care, pharmaceutical and biotech industry.
QSI was established in 2001 and has been serving the medical device and pharmaceutical industry with hands on industry relevant consulting for over a decade.
See our impressive portfolio.
Associates of Cape Cod
Charles River Laboratories
American Red Cross
Pennsylvania Regional Tissue Bank
Control Delivery Systems
Cancer Vaccine Industry
Medical Device/Biologics Industry