In order to keep the pace of innovation while adapting to changes in global demand, Pharmaceutical companies are more reliant than ever on a variety of vendors and other third parties including contract research organizations, contract manufacturers, and various IT vendors. While these third-party relationships are enabling Pharmaceutical companies to stay competitive in an ever-changing global economy with increasing regulations, these complex third-party ecosystems has created a data supply chain fraught with unprecedented risk for Pharmaceutical companies. Given that this highly sensitive data often includes drug formulas and other intellectual property, medical records, research data, and financial data, Pharmaceutical companies and their parties have increasingly become targets of cyber criminals.
To further complicate matters, as more Pharmaceutical companies move to cloud-based applications and services to handle onerous tasks involving big-data, they are creating a significant compliance risk. The Food and Drug Administration (FDA) regulations in 21 C.F.R. Part 11 requires organizations who “use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.” Ensuring that vendors and other third parties have established the proper controls and are able to provide the necessary audit trails, is of critical importance.
Since 2004, Prevalent has enabled pharmaceutical organization to safeguard highly sensitive data across their data supply chain, ensure compliance with ever-increasing regulations, and lay the foundation for a robust third-party risk management program.
Prevalent Vendor Risk Manager (PVRM) allows pharmaceutical organizations to better manage and monitor risks posed by third and fourth-party business partners and vendors. The solution automates the collection of third-party information in a secure and scalable way, helping better understand the risks of your data supply chain. In addition, PVRM 3.0 now integrates with Prevalent’s newest product, Prevalent Vendor Threat Monitor, enabling you to leverage dynamic, real-time vendor risk information collected from external sources; enabling better visibility and monitoring between your assessments.