Box Delivers Next Generation Compliance Monitoring With “Always-on” GxP Validation for Life Sciences
January 18 2018 - 12:00PM
Business Wire
Accelerates Validation and Enables Seamless
Collaboration of Regulated and Non-regulated Content on a Single
Platform
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 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:
- 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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Box, Inc.Ashley McCluskyashley@box.com
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