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Cloud Content Management with Automated GxP Compliance Built In

Data in the Cloud Can Be 21 CFR Part 11 Compliant

Learn how Box and USDM Life Sciences deliver a trustworthy digital experience for life sciences companies.

Ensure GxP compliance when collaborating inside and outside your organization.
Download the white paper to learn how > > >

What is cloud content management? It’s a system that allows authorized users inside and outside of your organization to access and share information on desktop and mobile devices. Cloud content management addresses how content is protected, governed, and used. It also includes file sharing, storage, and permissions.

Go Digital and Leave Paper-Based Processes Behind

As a life sciences organization, your GxP-related equipment, systems, and processes must be validated and meet compliance criteria set by global regulatory bodies.

To help you share data while complying with global GxP requirements, Box standardizes regulated and non-regulated content in one best-in-class cloud content management system. USDM Cloud Assurance provides supplemental procedures and updates to Box validation documentation to ensure that your organization maintains its validated state.

Box provides baseline validation documentation, an automated testing tool (ATT), and test reports. USDM Cloud Assurance conducts the initial Box validation and provides supplemental procedures, quality assurance, and compliance monitoring.

Learn more about the Box GxP and Cloud Assurance partnership for
cloud content management—get the white paper > > >

Explore Life Sciences Use Cases for Cloud Content Management

Discover how Box and USDM support various use cases, including:

  • Virtual audits and inspections. Publish regulated documents in read-only format using Box GxP Validation and track what auditors are accessing and reviewing to ensure transparency. 
  • Clinical collaboration. Maintain the chain of custody for contract research organizations (CROs) and contract manufacturing organizations (CMOs) collaboration. 
  • Quality document management. Create, share, and exchange policies, standard operating procedures (SOPs), and work instructions (WIs) in one repository across applications and services. 
  • Commercial purposes. Give field reps access to promotional material from anywhere and on any device. Prevent them from sharing confidential information by restricting access to confidential files. 
  • Data migration. Maintain a consistently validated state of your infrastructure and platform. Identify databases, applications, and storage options using a data migration plan to avoid the “garbage in, garbage out” syndrome.

Get the details when you download the cloud content management white paper > > >

Automate Compliance Workflows and Maximize Your Investment

To automate compliance workflows and digitize processes throughout your organization, implement Box Relay and any of the thousands of integrated applications that Box supports. You’re able to create customized workflow templates for R&D, commercial, and manufacturing. It enables solutions for GxP business processes that impact your clinical, quality, and laboratory functions.

Save time and effort in your vendor requalification efforts and receive a defensible annual vendor audit for the U.S. Food and Drug Administration (FDA) using USDM’s Cloud Assurance. In conjunction with Box GxP, Cloud Assurance is a validation accelerator to achieve validation in weeks, not months. You don’t need a costly, in-house validation team to manage daily, weekly, and monthly updates.

The USDM automated testing tool was created for Cloud Assurance to automate the regular testing of Box GxP requirements. It satisfies change management requirements and supplements hundreds of automated tests that Box runs every day.

Learn more about automation when you download this white paper > > >

Collaborate. Share. Manage. This joint solution from Box and USDM delivers a continuously validated and secure platform that simplifies GxP compliance. Contact USDM to get started. 

White Paper

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