Partnership
Box GxP Compliance
Make regulatory compliance a competitive advantage by instituting a strategy for audit-ready regulated content management and deploying tools to maintain operational efficiency.
Box GxP supports a variety of life sciences use cases, including contract research organization (CRO) and contract manufacturing organization (CMO) collaboration, clinical collaboration, clinical dataset management, Quality document management, mergers and acquisitions (M&As), and post-merger integration (PMI).
Maximize your return on investment (ROI) of the Content Management System (CMS) and optimize Box throughout your organization with comprehensive USDM services to support your use cases.
Learn how an oncology research company found a centralized solution for storing data in a secure and continuously compliant system.
A Comprehensive Content Management Solution for Compliance and Data Security
Maintain compliance, mitigate risk, and optimize content management while ensuring the trustworthiness of your data throughout business operations. The Box and USDM partnership provides your life sciences organization with a cloud content management solution that ensures efficiency, security, and continuous GxP compliance.
Contributing to this partnership, USDM’s Trust & Compliance capabilities include:
- Data Integrity & Transparency: Content in Box remains accurate, complete, and reliable. You’re able to track data changes, provide full transparency to regulators, and maximize the auditability and accountability of stored data.
- Cybersecurity & Risk Management: Cybersecurity measures ensure that Box meets regulatory requirements for data protection. You’re equipped to guard sensitive information with proven risk-management practices and ensure that internal and external collaboration is protected against cyber threats.
- Continuous Compliance & Validation: USDM Cloud Assurance accelerates validation, automates ongoing testing, and promises continuous compliance. Validation lifecycle management using ProcessX ensures that Box remains compliant with GxP standards, which allows your teams to focus on innovation.
- Audit Readiness & GxP Support: Your Box system is always audit-ready. Built-in audit trails, automated testing tools, and customer-specific use case validations contribute to an audit-ready environment.
USDM’s Content Management capabilities further complement your Box platform with:
- Content Strategy & Design: A structured and compliant framework ensures that your content is well-organized, accessible, and ready for effective cross-functional collaboration.
- GxP Best Practices: Best practices for compliance include effective metadata management, secure collaboration, version control, and retention policies. They also support audit readiness by maintaining a complete history of changes to protect data integrity.
- Document Lifecycle Management: USDM facilitates document creation, approval, storage, and disposal to ensure compliance throughout the entire document lifecycle. This includes maintaining version control, setting access permissions, and ensuring that documents are reviewed and updated as needed.
- Content Readiness for GenAI: For your content to be used effectively by generative AI (GenAI) tools, USDM helps you maximize content by formatting and organizing it in a way that supports advanced AI-driven insights.
Expanding on Box + USDM Cloud Assurance
Offered with Box, USDM Cloud Assurance accelerates initial validation and generates a leverageable annual vendor audit. The USDM automated testing tool (ATT) replaces manual operational qualification (OQ) and provides ongoing regression testing of core requirements.
To keep you continuously compliant, Cloud Assurance tracks, assesses, and reports on Box updates and daily system functionality testing. It also executes automated testing scripts after every release and enhancement—not just at implementation. Cloud Assurance Premium adds customer-specific use case testing after every update.
To ensure a complete testing package, the Box ATT and USDM ATT each cover about 40% of Box core GxP requirements testing, and the remaining 20% of requirements are tested by both of us.
Read how a biopharmaceutical customer with little GxP regulatory experience achieved validation of their Box instance and CSV-compliant deliverables.
Simplify GxP Application Implementation, Governance, and Enhancements
Work from a single source of truth to manage Validation Lifecycle Management (VLM) and Application Lifecycle Management (ALM) when Box is integrated with USDM’s proprietary ProcessX workflow automation platform.
End-to-end lifecycle management with ProcessX includes:
- Pre-configured and pre-validated GxP workflows to alleviate your compliance burden
- Built-in audit trails and eSignatures to simplify regulated workflows and meet global regulations, including FDA 21 CFR Part 11 and ISO 9000
- Integrated test automation to shorten cycle times and reduce costs
- A single source of truth for compliance management that links change control processes with validation activities
- Audit readiness by quickly generating a traceability matrix, automated testing results, and a Validation Summary Report
- Pre-built validation and test automation packages to speed up GxP system management; packages include requirements planning and test automation for systems like Box, DocuSign, Veeva, SAP, and Oracle
Explore the Benefits of Box GxP for Cloud Content Management
Standardize regulated and non-regulated content on a single cloud content management platform—it’s all backed by enterprise-grade security and compliance.
Create, collaborate, manage, and share information. Explore the benefits of Box GxP for cloud content management:
- Frictionless Security and Compliance: Ensures data is secure and meets regulatory standards.
- Seamless Internal and External Collaboration: Facilitates efficient workflows and collaboration.
- Better Execution of Virtual Audits: Streamlines processes for remote regulatory audits.
- Compatible with Business Apps: Easily integrates with over 1400 applications for enhanced process automation.
- Scalability: Adapts to evolving business needs without massive investments in new technology or licenses.
Establish regulated content and data management strategies right from the start. Contact USDM today.
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