Facilities

Quality Solutions, LLC can assist in establishing requirements for your manufacturing facility while identifying appropriate facility solutions. Our experience with new and retrofitted facilities allows us to recommend process utility changes, design changes, confirm timelines, and identify suppliers that will keep projects on time and within budget.

Our involvement in the design, equipment selection, construction, commissioning, and start-up process ensures that validation activities are streamlined, therefore substantially reducing time and costs. This Quality By Design approach gives clients an advocate during the design and construction phase who considers quality and CGMP compliance from the conceptual design phase through project turnover.

Services include:

• • Design Qualification
• • Construction Management
• • CGMP Compliance and Optimization

An effective Quality System must contain robust and practical components that are developed with a clear understanding of all regulations and guidelines. We can provide the essential services needed to create, improve, or refine your Quality System.

Services include:

• • Master Planning
• • Regulatory Support
• • Gap Analysis/Impact Assessments
• • SOP Development

Our trained technicians arrive at your site with the necessary tools and NIST traceable testing equipment to perform the scope of work. You will receive As Found/As Left data and Testing Equipment calibration certificates for each instrument calibrated.