A container full of pharmaceutical products, whether over the counter drugs, biologics, blood products, vaccines, or clinical trial materials, is a highly valuable asset that is subject to various risks while under transport. Whether securing the cargo from theft, monitoring it for temperature or other conditions that could impact the effectiveness of the products, or responding efficiently to FDA audit requests with electronic chain of custody information, manufacturers and transporters face significant business challenges in securing and documenting their supply chains.
Hi-G-Tek’s solution enables customers to monitor biometric conditions, in real time if needed; to electronically secure the cargo itself and to be alerted to instances of tampering if required; and to readily respond to audit requests with electronic reporting that includes chain of custody information, as well as establishing biometric conditions, during the entire transport process.
Sensing and security are the key components of Hi-G-Tek’s technology. The company’s solution is composed of electronic sensing and locking devices and an enterprise services platform (ESP). The ESP receives, analyzes, and stores all the information collected by the sensing devices, applying the client’s business rules to the data, generating alerts where appropriate, and storing data history. This history facilitates FDA audit compliance by documenting all points of custody, as well as the parameters that are set for biometric condition monitoring.
Hi-G-Tek’s solution addresses the business challenges faced by manufacturers, wholesalers, and distributors. Some of the specific benefits include:
• Chain of custody documentation
• Documentation of biometric parameters
• Risk mitigation
• Reduce theft and assist recovery
• Audit compliance
• Reduction in the need to quarantine products
• Improved operational efficiency