Regulatory Compliance

Quintiles Outcome’s programs are developed and validated in compliance with applicable federal guidelines pertaining to data that is submitted to the FDA (21 CFR Part 11) as well as additional FDA and international guidance documents. These regulations include specifications on the use of electronic signatures, the maintenance of an audit trail, and the physical and logical security of the system.

All of Quintiles Outcome’s solutions are also fully privacy compliant and mesh seamlessly with an organization’s existing privacy protocols. Quintiles Outcome has extensive experience in customizing products for healthcare organizations and biopharmaceutical companies and has worked closely with them to ensure privacy compliance, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU Privacy Directive.