DHS Threat Advisory

The Life Sciences industry continues to be one of the most diverse, demanding, and constantly changing businesses. Mergers and acquisitions, patent expirations, governmental regulations, and regularly emerging, new technologies pose challenges in all aspects of Biotechnology, Healthcare and Pharmaceuticals.

Life Sciences companies are particularly challenged by the need to streamline the process of using external resources to provide independent testing of new drug research and development. Protecting intellectual property, guarding and maintaining the validity of research information and adhering to mandated 21CFR Part 11 and Part 820 regulations impact their profitable time to market.

Global communication with disparate Clinical Research Organizations (CRO’s) has become increasingly difficult. Protecting, transmitting and auditing both data and communication is expensive and time consuming. The security enjoyed in a controlled environment that utilizes Virtual Private Networks, secure email and identity management are lost when dealing with outside resources and remote communications. Secure email cannot be audited, VPNs require hardware and software deployment and identity management does not flow throughout the organizations.

SentryPort SAFE™ addresses these issues in a simple to use yet powerful, 21CFR Part 11-ready solution. SentryPort SAFE can be deployed in minutes, not days or months, with minimal expense and maximum impact.

The SentryPort Solution allows our clients to gain a competitive edge in clinical research and dramatically reduces the high cost of mandated validation and compliance issues.

With technology products that directly address the issues of Part 11 and HIPAA, SentryPort is uniquely poised to be the preeminent solution provider for life science and healthcare companies seeking to achieve regulatory compliance. Internal Review Boards, Clinical Research Organizations, investigators and regulators can distribute confidential documents securely and instantly with SentryPort SAFE.

SentryPort SAFE™

• Encrypted information management system (transport/retrieval/audit/storage)
• NIST validated; FIPS 140-1 compliant; 21 CFR Part 11 ready
• No client-side software – deployment is easy and cost effective
• Forensic-level audit trails of user and managed service administration activity
• Preserves digital rights as required by clients and mandated regulations
• Encompasses the needs of a trusted community
• Requires only a Web browser to operate
• Can be web- or server-based

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