Accelerates Validation and Enables Seamless Collaboration of
Regulated and Non-regulated Content on a Single Platform
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:
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Exchange clinical content between sponsors, Clinical Research
Organizations (CROs), contract manufacturing organizations,
and investigator sites;
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Collaborate and exchange regulated content during joint development or
M&A activities;
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Secure archival of Standard Operating Procedures (SOP) and clinical
study documentation;
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Remain compliant with 21 CFR Part 11 requirements by integrating Box
with an eSignature provider of choice, like Adobe Sign and DocuSign;
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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 change in
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:
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Box
Zones: Addresses in-region data residency requirements across the
globe.
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Box
Governance: Enables customers to comply with regulatory policies,
satisfy e-discovery requests and effectively manage sensitive
information.
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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.
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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.
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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.
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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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180118005496/en/
Source: Box, Inc.