Among the key features of the system are support for Corrective Action Preventive Action (CAPA) processes, capabilities to help prepare for internal and regulatory audits, tools for tracking and validating employee training and regulated document management. Each of these functions is important, as oversight and compliance within the life science industry can be complex, and being able to track and access documentation is a ongoing need. The regulated document management features merit particular note, as they support navigating the choppy waters of compliance with the electronic records provisions of the U.S. Food and Drug Administration, as well as supporting the FDA's Pharmaceutical, Biological, and Medical Device best practices guidelines.
Open Text is an interesting company, in that it has built up a base of more than 45,000 customers by creating niche solutions across multiple industries. It has particularly deep support for the pharmaceutical and life sciences industry, and Livelink ECM - Quality Management System looks as though it will fill a gap. It's worth looking into its products as part of any evaluation.