Box GxP
Centralize your regulated and non-regulated content
Global leaders protect regulated content with Box
Standardize your regulated and non-regulated content in the cloud
Box GxP Validation enables pharma and life sciences organizations to validate Box so they can work with, manage, and distribute all of their clinical, lab, and quality content. By standardizing both your regulated and non-regulated content with the Content Cloud, you get collaboration, mobility, enterprise-grade security, and compliance on a single content platform.
Power better collaboration on one secure platform
Collaboration is easy with the Content Cloud: You can work securely with internal teams as well as medical care providers, government agencies, and clinical sites. We also help you eliminate inefficient silos between multiple repositories (and decommission expensive legacy GxP repositories). Plus, with all your content on one secure, compliant platform, you don't have to worry about whether your most sensitive data is safe.
Speed up validation with regular testing
We test core Box functionality regularly (and you can always see the results), so you don't have to run your own validation tests to be compliant. And with a GxP dashboard and GAMP5-validation templates designed specifically for cloud platforms, you can save on validation costs and retire legacy validation programs.
Innovate faster with 21 CFR Part 11 compliant e-signatures right where your content lives
Box customers leverage the power of the Content Cloud to digitally transform their documents and records. With natively integrated e-signatures via Box Sign, you can extend those digital transformation benefits to internal and external business processes requiring signatures, and enable a broader set of workflow capabilities with a multitude of stakeholders, including suppliers, CMOs, CROs, and more.
Secure your regulated processes with confidence
Virtual inspections and audits with regulatory bodies
Ensure controlled and compliant virtual inspections and audits with regulatory bodies by using one central platform to create and quickly share policies, SOPs, and other regulated documents.
Collaboration between sponsors and CROs
Speed up research exchange of regulated and non-regulated clinical assets between sponsors and external alliances, such as clinical research organizations (CROs) or research partners.
Clinical collaboration with compliant, remote site monitoring
Securely monitor clinical study sites and verify source documents with Box GxP Validation, using granular permissions, file request and automated disposition.
The Content Cloud integrates with your favorite apps
Box GxP Validation works with our integration partners to provide a unified workflow — which helps you achieve transparency and efficiency while maintaining compliance. With the Content Cloud, you get one platform to support regulated and non-regulated business processes across your organization.
Key features
Automated testing
Transform testing and compliance for enterprise cloud applications.
GxP dashboard
Get results of Box automated testing, with regular verification of Box functions, and features.
Quarterly controlled releases
Features are released quarterly, and customers are given a 30-day preview period for validation activities.
Baseline validation documents
The Validation Accelerator package (based on GAMP5) includes all validation lifecycle documents, with guidance for validating Box for regulated content.
21 CFR Part 11 compliance
Maintain 21 CFR Part 11 compliance for electronic records by enabling a combination of data management features and approve documents using electronic signatures in Box Sign.
Expanded GxP coverage
Leverage automated testing for Box Governance, Box Platform, and Box Relay.
Content audit trail
Maintain an audit trail with version control, allowing you to easily preserve and restore previous versions of files and leverage audit logs and historical reporting for additional insights.
Configurable workflows
Create workflows with automation, and build validation around them to speed up processes.
Secure collaboration
Manage and verify user access with flexible admin tools, and protect content with seven user-friendly sharing roles, allowing for easy external collaboration on regulated content.
Learn more about securing your content with Box GxP
