Box and USDM work together to keep your information GxP compliant in the cloud

Organizations in the life sciences industry, including pharmaceuticals, biotech and medical device companies, are rapidly transforming. Outsourcing is increasingly commonplace, and a continuous rise in M&A and joint ventures is fueled by a desire to rationalize portfolios and speed up innovation to bring therapies to market. While effective collaboration and speed to market remain critical for market leadership, a lack of effective risk management of intellectual property and proper information governance on regulated systems can lead to regulatory fines, legal exposure and revenue loss.

Due to this complexity, life sciences organizations haven't been able to move their content to the cloud as aggressively as they'd like. Many maintain legacy on-premises ECM systems in order to meet stringent guidelines issued by the FDA and other regulatory bodies on how information is stored, managed and distributed when it pertains to drug development, medical device development, clinical trials and patients. These systems, inflexible to user needs and time-consuming to maintain and validate, have created inefficient silos between regulated and unregulated information, and have slowed down collaboration and innovation.

Manage regulated and unregulated content with Cloud Content Management

At Box, our mission is to help organizations transform the way they work, even in the face of all this complexity. We now have Box GxP Validation, an innovative approach for maintaining GxP compliance in the cloud, which enables organizations to leverage a single secure, compliant Cloud Content Management platform to manage both unregulated and regulated content. Life sciences companies can now create, collaborate, manage, distribute and archive regulated content associated with clinical development and manufacturing processes.

Box GxP Validation provides customers with a Validation Accelerator Pack (VAP) and daily testing to qualify and maintain compliance of their Box instance. The innovative validation methodology from Box accelerates initial validation and lowers risk with the use of daily automated tests to assure a continued state of compliance for the Box platform. With access to regulated and unregulated content in a single repository that's highly secure, compliant and accessible anywhere, customers can find the information they need, whenever they need it, in a cost effective manner.

As part of Box GxP Validation, Box is partnering with USDM, a leading firm for risk management, technological innovation and business process for life sciences, to provide Cloud Assurance, a service that validates changes in the production environment of Box. USDM can also work with customers to ensure their own configurations and customizations are unaffected by these changes.

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