News | January 18, 2018

Box Delivers Next Generation Compliance Monitoring With ‘Always-On' GxP Validation For Life Sciences

REDWOOD CITY, CALIF.--(BUSINESS WIRE)--

Box, Inc. (NYSE:BOX), a leader in cloud content management, today announced Box GxP Validation, an innovative new approach for maintaining GxP compliance in the cloud. Box GxP Validation enables Pharmaceuticals, Biotechnology and Medical Device businesses to develop, validate and operate their GxP compliance standards within Box. Box GxP Validation methodology complies with GAMP5 guidelines, accelerates the validation process, and lowers risk via use of daily tests to assure a continued state of compliance for the Box cloud content management platform.

“As content increasingly becomes a more integral part of how life sciences organizations deliver the next generation of therapies to improve health and wellness, we’re excited to provide GxP Validation within Box so that customers can seamlessly manage both unregulated and regulated content in one centralized cloud content management platform,” said Riju Khetarpal, Managing Director, Box for Life Sciences. “With GxP Validation, companies in regulated industries can eliminate inefficient silos between regulated and unregulated information, and speed up collaboration and innovation.”

Box GxP Validation creates new opportunities for customers to build, 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. Box GxP Validation provides businesses in the life sciences industry with a Validation Accelerator Pack (VAP) and daily reports to show that Box is functioning as intended to qualify and maintain compliance of their Box instance, so that they can:

  • Exchange clinical content between sponsors, Clinical Research Organizations (CROs), contract manufacturing organizations, and investigator sites;
  • Collaborate and exchange regulated content during joint development or M&A activities;
  • Secure archival of Standard Operating Procedures (SOP) and clinical study documentation;
  • Remain compliant with 21 CFR Part 11 requirements by integrating Box with an eSignature provider of choice, like Adobe Sign and DocuSign;
  • Leverage Box as a compliant content layer with life sciences ISV and SI partners.

As part of Box GxP Validation, Box is partnering with USDM, a leading risk management, technological innovation and business process optimization firm for the life sciences and healthcare industries, to provide Cloud Assurance, a new compliance maintenance methodology that continually tests all key functionality of the Box service prior to its release into production. Cloud Assurance validates changein the production environment to ensure that the change has not impacted the intended use of the service. USDM also works with clients directly to ensure their own configurations and customizations are unaffected by these changes on a case by case basis.

“At USDM, we specialize in risk management, compliance, and business process optimization for the life sciences industry,” said Kim Hutchings, Head of Alliances/Digital Transformation Lead at USDM Life Sciences. “We are excited to bring our industry expertise together with Box to enable heavily regulated life science businesses to fully transition to a cloud content management platform that supports both regulated and non-regulated content and create streamlined workflows that speed up innovation.”

Since announcing Box for Life Sciences in August of 2014, Box has seen continued momentum in the life sciences industry, with customers including: Eli Lily, AstraZeneca, Jazz Pharmaceuticals and Boston Scientific. Box for Life Sciences enables organizations across the globe to safeguard their most sensitive content, while securely collaborating between teams and partners, by providing the following capabilities and services:

  • Box Zones: Addresses in-region data residency requirements across the globe.
  • Box Governance: Enables customers to comply with regulatory policies, satisfy e-discovery requests and effectively manage sensitive information.
  • Box Platform Allows organizations to leverage the underlying technology that powers Box in their own custom applications to deliver more powerful digital experiences to their constituents.
  • Box Keysafe: Enables organizations to gain independent control over their content encryption keys without sacrificing the ease of use or limiting the powerful collaboration features of Box.
  • Box Transform: Accelerates digital transformation through a white-glove program that offers customers a dedicated, long-term Box consultant to drive implementation of advanced cloud content management use cases.
  • Additional Compliance: Box supports HIPAA compliance and signs HIPAA Business Associate Agreements with its customers and partners.

For more information on today's announcement, please visit the Box blog and join the live webinar to be held on Wednesday, February 14th at 10am PT/1pm ET.

About Box

Box (NYSE:BOX) is the cloud content management company that empowers enterprises to revolutionize how they work by securely connecting their people, information and applications. Founded in 2005, Box powers 80,000 businesses globally, including AstraZeneca, General Electric, P&G, and The GAP. Box is headquartered in Redwood City, CA, with offices across the United States, Europe and Asia. To learn more about Box, visit http://www.box.com.


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