Regulatory requirements around the world have grown, creating heavy workloads of documentation and the need for process transparency. In addition to rising compliance concerns, Life Sciences organizations face increased security measures, including HIPAA, FDAA 2007 and more.
Regulatory risk is the possibility of being out of compliance. For many Life Sciences companies, regulations rule your compliance objectives. How you handle it is based on your product, production processes and your level of tolerance for risk. A high tolerance for risk might equate to lower compliance costs, but potentially higher non-compliance penalties.