Organizations create processes, but the question is how effective are they? How robust are these processes? Are they able to adhere to management’s near and long term goals? Organizations need to continuously examine what is in place or what is needed to meet regulatory and industry expectations. They need to ensure they can expand to meet these expectations and/or streamline to avoid complexities that impact compliance. Late stage, pre-commercial companies are universally busy. Making the transition from product development to commercial is an exciting yet challenging time. Current employees must wear multiple hats and stretch their skill sets. The company is likely hiring more talent to help with the transition, resulting in an increasingly diverse set of perspectives and experiences. The priorities of these companies are typically product development, trial completion, product/process validation, regulatory preparation, and commercial launch preparation, all while ensuring the necessary finances to support it all.
Through years of experience working with client partners and helping to develop and strengthen their Quality Systems and processes, Clarkston Consulting has developed Overwatch. Built upon the challenges faced by our clients and their need to accelerate the build and robustness of a compliant quality system, Overwatch provides a fresh perspective to your QMS growth and development and delivers significant improvements in operational efficiency and compliance position. Providing Overwatch as your organization grows through the Quality Lifecycle stages, along with the ability to modify the Quality System as needed, results in a compliant customized solution.
To learn more about the Clarkston Overwatch methodology, review the slideshow below.