Compliance Analytics

An American Biotechnology Company had implemented a quality management system to manage quality assurance and quality control in its manufacturing processes. However, it was unable to obtain the required insights into its quality control data at the highest and the most detailed level. This led to business challenges such as lack of adherence to regulatory requirements, long time-to-market to launch products, high risk of product recalls, high overall cost-to-quality. Hence, it wanted to implement an analytics solution that would provide it the required insights into its quality control data.

DiLytics implemented a Compliance Analytics solution that automated the transmission of data from quality management system to the target system and provided reports and dashboards that gave distinctive views of quality control data via charts, tables, and calculation results.

The solution enabled the client to easily view compliance levels across its sites and products, and facilitated compliance with industry best-practice standards and Food and Drug Administration Safety and Innovation Act (FDASIA) reporting expectations.