Partnership
Box GxP Compliance
Audit-Ready Regulated Content Management Strategies
To maximize the return on investment (ROI) of your Box Content Management System (CMS) and improve regulated content management, USDM provides a comprehensive suite of services and solutions. When your life sciences organization has the tools and expertise it needs to maintain compliance and operational efficiency, achieving regulatory compliance becomes a competitive advantage.
Comprehensive Services to Support Box GxP Use Cases
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). USDM’s services help to optimize the use of Box throughout your organization.
Learn how an oncology research company found a centralized solution for storing data in a secure and continuously compliant system.
Box + USDM Cloud Assurance Simplifies Compliance
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.
Lifecycle Management with Box and ProcessX
When integrated with USDM’s proprietary ProcessX workflow automation platform, you get a single source of truth to manage Validation Lifecycle Management (VLM) and Application Lifecycle Management (ALM). It simplifies how you govern the implementation, upgrade, or enhancement of your GxP applications.
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
Advantages of Box GxP for Cloud Content Management
Your life sciences organization can create, collaborate, and manage information, then distribute it to employees and partners—all backed by enterprise-grade security and compliance. Regulated and non-regulated content can be standardized on a single cloud content management platform.
Additional benefits of Box GxP include:
- 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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