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Quality By Design

Quality Solutions can assist in establishing requirements for your pharmacy operations while identifying appropriate facility solutions. Our vast experience with new and retrofitted facilities allow 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 all activities are streamlined, therefore substantially reducing costs and saving time. Our goal is for your facility to avoid construction delays, project rework, and all regulatory issues post turnover. Thus avoiding additional costs and pharmacy downtime. This Quality by Design approach gives clients an advocate during the design and construction phase who considers quality and compliance from the conceptual design phase through project turnover.

Design Qualification

This critical and often underutilized step in the product/project lifecycle provides an opportunity for all stakeholders to define the functional specifications of the equipment or system, while taking into account scientific, quality, business, and operational considerations. Quality Solutions can bring their expertise to the table to help manage and contribute to this important process.

USP <797> <800> Compliance and Optimization

Quality Solutions can review and evaluate your pharmacy operations in new construction or building retrofit projects and make recommendations to improve efficiency while considering applicable regulations.

Construction Management/Client Agent Services

We can provide expertise to manage or assist in the coordination of your facilities construction and commissioning phase. In addition, we can offer support services to witness all start-up services to ensure any system or quality requirements are met at the time of contractor turnover.

Services include:

  • Review Architectural and Engineering Plans
  • Assistance with Commissioning Plan
  • Test Procedure Design with all contractors
  • Project Management
  • Vendor and Contractor management
  • Commissioning Execution
  • Start-up services

“Save time and costs upfront vs. delays after turnover”

Quality Solutions

Quality Solutions News & Announcements

Founded in 2001 as a validation services provider, Quality Solutions has grown into a leading compliance and support partner for the biotech, healthcare, and pharmaceutical industries. With offices in Maryland and Utah, we execute projects both nationally and internationally, offering tailored, cost-effective solutions to meet FDA regulations, USP 797/USP 800 guidelines, and broader quality management needs. Our comprehensive services—including facility design, calibration, validation, and environmental certification—ensure seamless compliance and operational efficiency. With an integrated certification team and in-house lab, we deliver fast, reliable results, minimizing risks and costly delays. At Quality Solutions, we take a long-term partnership approach, acting as your insurance policy for maintaining compliance while maximizing the financial return on quality investments.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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