Introducing Box GxP Validation: Compliance for an Agile Cloud

BY RIJU KHETARPAL / NEWS

Organizations in the life sciences, 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, firms can experience regulatory fines, legal exposure and loses in revenue without effective risk management of intellectual property, and proper information governance on regulated systems.

Due to this complexity, life sciences organizations have not been able to move their content to the cloud as aggressively as they would like. Many maintain legacy on-premise 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, created inefficient silos between regulated and unregulated information, and slowed collaboration and innovation.

Manage regulated and non-regulated content on a single cloud

At Box, our mission is to help organizations transform the way they work, even in the face of all this complexity. Today, we are excited to announce Box GxP Validation, an innovative approach for maintaining GxP compliance in the cloud which enables organizations to leverage a single secure and 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 a Validation Accelerator Pack (VAP) and daily testing to qualify and maintain compliance of their Box instance. Box’s innovative validation methodology accelerates initial validation and lowers risk via use of daily automated tests to assure a continued state of compliance for the Box platform. With access to regulated and non-regulated content in single repository that is 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 risk management, technological innovation and business process optimization firm 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.

One Cloud Platform for a Full Range of Use Cases

Box GxP Validation creates new opportunities for customers to create, manage, collaborate and distribute regulated content in Box as they work cross-functionally within their organization or with external business partners that are critical to the clinical development and drug manufacturing processes. We’re excited to enable new life sciences use cases with Box, including:

• Exchange of clinical content between sponsors, CROs, CMOs, and investigator sites
• Collaboration and exchange of regulated content during joint development or M&A activities
• Secure archival of SOP’s and clinical study documentation
• Compliance with 21 CFR Part 11 requirements by integrating Box with eSignature providers
• Use of Box as a compliant content layer with life sciences ISV and SI partners

Today, 800+ life sciences organizations are Box customers, including Eli Lilly, Boston Scientific, GlaxoSmithKlein, AstraZeneca, Boston Scientific, Edwards Life Sciences, Daiichi-Sankyo and Shionogi, leveraging Box to securely and compliantly manage day-to-day operations, research, sales, marketing and global product launches. With the announcement of Box GxP Validation, we will be able to transform the way these organizations and many other work — with both regulated and unregulated content.

To hear more about this new game-changing model for maintaining GxP compliance in the cloud, register for our upcoming webinar, Meet Box GxP Validation: Regulated and unregulated content, now in the same cloud. In the meantime, read up on the Box GxP Validation methodology.

Enabling new compliance capabilities in life sciences is just one example of how Box recognizes the importance of compliance strength in the cloud. Look out more compliance strength from Box, coming soon.