ABOUT US

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Quality System Professionals, LLC (QSP) was established in 1999 with the mission to provide high quality validation and technical services to the pharmaceutical, biotechnology, and medical device industries. Since that time QSP has expanded its services and gained experience working with a wide range of projects with a diverse group of clients. QSP provides full service Validation and cGMP Compliance consulting servicing the regulated industries. QSP specializes in the preparation and execution of validation and compliance documents for equipment, utilities, processes, laboratory instruments, and computerized systems. QSP can perform individual tasks, or manage and execute complex validation projects from the development of a Validation Master Plan through FDA approvals. All projects, regardless of size, are given the same professional attention and management.

Strategy

QSP is an industry leader with a proven approach to Validation and cGMP Compliance consulting. QSP provides industrious and experienced consultants who complete projects on time and on budget. Emphasis is given to strong project management and innovative thinking that enhances the quality and value of our services.  QSP provides the desired level of detail and customization to your documentation, emphasizing regulatory trends that impact the level of detail required. QSP can look at your company’s unique situation objectively, uncover your needs and priorities, clearly define project requirements, and tailor our services accordingly.

 Quality Assurance

A proven approach to validation and compliance that delivers work guaranteed to comply with the cGMPs. All activities are governed by an extensive set of internal SOPs that are regularly revised.

Project Management

Effective on-site Project Management controls the scope and project costs, ensures reliable delivery of services, allows for innovation, and reduces the client’s overall exposure to risk.

Diverse Team Approach

Projects are staffed with consultants with considerable experience and diverse educational backgrounds including chemistry, pharmacy, microbiology, engineering, metrology, and IT.