Serán Bioscience, LLC, located in Bend, Oregon, is a reputable industry leader in clinical manufacturing, offering a wide array of services including API particle size reduction, spray dried intermediates, final dosage forms, and packaging. With decades of experience in drug development, Serán excels in understanding the unique challenges and solutions required for each project. As part of their commitment to continuous improvement and increased service quality, Serán identified an opportunity to optimize their document management process.
Serán Bioscience recognized that their document management required enhancements to better support their employees in accessing the most current information. To ensure the highest level of compliance and product quality, Serán sought to implement a more efficient and consistent method for managing document changes and controlling obsolete documents.
In pursuit of improved efficiency and service quality, Serán Bioscience implemented a state-of-the-art electronic document control system. Novunex eQMS Document Control enabled authorized personnel to consistently execute product changes and provided a centralized platform for document management. The new system streamlined processes, ensuring that employees had access to the most up-to-date and approved versions of documents.
By adopting the electronic document control system, Serán Bioscience achieved notable improvements in the efficiency and accuracy of their documentation processes. The centralized platform facilitated easy access to released documents and automated the removal of obsolete files. This new system enabled Serán to reduce the time needed for processing document changes by over 45%. As a result, the company could allocate more resources to enhancing the quality of their services and meeting the unique needs of their clients.
This case study illustrates the positive impact of implementing the eQMS Document Control modules in a sophisticated pharmaceutical manufacturing environment. By addressing the document management challenge and introducing a more efficient and consistent method, Serán Bioscience reinforced their commitment to compliance, product quality, and exceptional service for their clients.