Abstract: A quality management system (QMS) contains a collection of documents and content relating to interdependent policies, processes, and procedures required for planning, manufacturing, and marketing complex products. Change management refers to the way a company manages modifications to products and processes within their business and the potential impacts of those changes. A core part of change management is to understand what may be impacted by the change, why it impacted, and how to assess and or identify the risk of the change throughout the company and quality/regulatory processes. The impact assessment is a core part of the process to ensure one does not make changes that create a product and/or process failures as well as evaluating the regulatory impact of such changes.

Abstract: This present disclosure relates to a system and method to manage compliance of regulated products. The system and method for managing compliance of regulated products includes qualitative and analysis of data obtained from within a company, across many companies, and from third party data sources to determine correlation, relevance, and importance of data points, as they relate to determining quality events, possible outcomes, risks and alerts, for the products.

Abstract: This present disclosure relates to a system and method to manage compliance of regulated products. The system and method for managing compliance of regulated products includes qualitative and analysis of data obtained from within a company, across many companies, and from third party data sources to determine correlation, relevance, and importance of data points, as they relate to determining quality events, possible outcomes, risks and alerts, for the products.