Delivering robust quality assurance and regulatory affairs solutions is Illinois-based QARS Solutions, a professional consulting services firm that serves as the change agents to help clients benefit from the value of quality. QARS Solutions is focused on developing quality management solutions that address the client's needs and are not only effective and efficient but sustainable for short and long-term success. QARS Solutions' consulting team is fully versed in quality systems, regulatory affairs, computer system validation, and process engineering. "Often, companies do not appreciate the value that quality brings as it requires a significant effort on their part. However, once the right quality management system is implemented, it delivers consistent results and only requires fine-tuning periodically to generate value," says Sharon Miles, Owner and Principal Consultant of QARS Solutions.
She further states, "Companies need to ensure their business is built on a rock-solid framework of a quality management system. They need to consider risk management, change management, resource planning, and regulatory compliance as elements critical in developing a quality management system that is a custom fit for the organization." QARS Solutions helps deploy the infrastructure required for the framework and execution of quality management systems. The firm provides audit services to evaluate quality management systems and identify opportunities for remediation and revision, as well as to ensure suitable engineering practices with repeatable and consistent results are in place.
QARS Solutions provides corporate compliance and strategy services to companies that face challenges with FDA Form 483, warning letters, and consent decree response. To further illustrate this, Sharon mentions the case of a client that was in trouble with the FDA and was on the brink of being pushed into a consent decree. QARS Solutions helped the client identify risks that needed to be addressed and implement the right corrective action and risk management plan. This involved executing the required corrections, revising the client's quality management system, and making it more fluid and lean, which is more suitable for the organization's size. With QARS Solution's help, the client successfully closed the warning letter from the FDA and brought the company back on track. After the project, Sharon continued to work with the client, and for over ten years, there has not been any problem regarding FDA investigations.
QARS Solutions’ consulting team is fully versed in quality systems, regulatory affairs, computer system validation, and process engineering
Sharon has also developed a quality management and process training program called QM3, which focuses on three facets: understanding personal development in quality, professional leadership in quality, and the products and processes of quality. The aim from now on is to enhance the QM3 to help companies ranging from start-ups to multinationals. QARS Solutions' foundation is based on accountability, integrity, and communication, elements without which quality cannot be achieved. Looking ahead, the company continues to help clients operate their quality management systems and ensure that it is sustainable in the long term while also ensuring that compliance regulations are being met.