OSIagen

OSIagen is a software company that provides solutions for the life sciences industry, primarily focusing on regulatory compliance and data management. Founded in 2005, the company aims to help pharmaceutical, biotechnology, and medical device companies streamline their operations and ensure adherence to strict industry regulations. Their core offerings typically revolve around electronic document management systems, quality management systems, and audit trail solutions.

The software developed by OSIagen is designed to manage critical documents throughout a product's lifecycle, from research and development to manufacturing and post-market surveillance. This includes features for document control, versioning, workflow automation, and electronic signatures, all of which are essential for regulatory submissions and audits. The company emphasizes the importance of data integrity and security within these systems, recognizing the sensitive nature of information in the life sciences sector.

OSIagen's solutions are often implemented to support compliance with regulations such as those set by the Food and Drug Administration (FDA) in the United States and similar bodies globally. By providing tools to manage and track changes to documents and processes, OSIagen assists its clients in demonstrating compliance and reducing the risk of regulatory non-conformance. The company positions itself as a partner in helping life science organizations navigate the complex regulatory landscape.