Continuous GxP compliant content management
USDM Life Sciences and Box provide an innovative approach for maintaining GxP compliance in the cloud. Life sciences organizations can create, collaborate, manage, and distribute information with their employees and partners—all backed by enterprise-grade security and compliance. All regulated and non-regulated content can be standardized on a single cloud content management platform. Download the Box GxP Validation datasheet to learn more about consolidating to a single platform.
Core Box GxP Benefits
- Frictionless security and compliance
- Seamless internal and external collaboration and workflows
- Better execution of virtual audits with the FDA
- Integration with all your business apps
USDM Cloud Assurance + Box GxP Benefits
As a core offering with Box, USDM Cloud Assurance Gold includes an annual vendor audit that you can leverage, an accelerated initial validation, and a USDM automated testing tool (ATT) that replaces the manual operational qualification (OQ) and provides ongoing regression testing of core requirements. And, to keep you compliant, Cloud Assurance tracks, assesses, and reports on Box updates and daily testing of core system functionality. Beyond Cloud Assurance Gold, Cloud Assurance Platinum adds customer-specific use case testing for every update.
Read how a biopharmaceutical customer with little GxP regulatory experience achieved validation of their Box instance and CSV-compliant deliverables.
Automated Testing Tools
Along with the Box ATT, you are ensured a complete testing package. The Box ATT and USDM ATT each cover about 40% of the Box core GxP requirements testing, and the remaining 20% of the requirements are tested by both of us.
Read more about how USDM created its ATT to automate daily testing of Box GxP requirements.
An Electronic Quality Management System
If you are interested in taking your Box GxP technology further, USDM integrates Box with ComplianceQuest to create the beginning of a complete EQMS in a continuously validated subscription called Unify Compliance Cloud. It is an innovative quality suite that enables Quality Document Management, Quality Change Management, and Training to significantly improve collaboration, control, and visibility over your quality management processes. Click to learn more about Unify Compliance Cloud or read our white paper, Digital Transformation of Content, Quality, and Compliance with Unify Compliance Cloud.
Box for IT Professionals
As you digitally transform your content and data management strategy, you and your IT team can trust that the core features of Box are functioning properly and keeping you continuously compliant. You further reduce risk because USDM manages Box releases for you. Perhaps best of all, you can decrease your spend by decommissioning expensive legacy GxP-compliant environments. You also benefit from:
- Expert management of your regulated and non-regulated content on a single validated platform
- Significantly reduced adoption, implementation, and validation time
- Flexible, open API platform with more than 1,400 integrations and process automations
- Enterprise-grade security delivered through a modern cloud platform
- USDM’s Cloud Assurance, which minimizes IT validation and change management efforts
Learn how an oncology research company found a centralized solution for storing data in a secure and continuously compliant system.
Box for Quality Professionals
Your Quality team can be sure that regulatory audits are set up for success with Box and USDM documentation and reports. In terms of remote audits, you benefit from a collaborative and efficient experience: There are no travel expenses for the auditor, there is compliance consistency, and you can reduce repetitive or inefficient interactions with personnel.
To automate compliance workflows, you can leverage USDM’s Workflow-as-a-Service with Box, Salesforce, and DocuSign. You can truly maximize your Box GxP investment with our solutions for business processes including GxP collaboration, clinical, Quality, and laboratory. You’ll also enjoy:
- Continuous compliance with USDM’s Cloud Assurance
- Easy collaboration for internal and external users (frictionless security)
- Better management and execution of virtual audits with the FDA and other regulatory agencies
- Scalability of use cases as your business needs evolve without massive expense in new technology or licenses
Contact USDM for your GxP-compliant content management solution.
Download the Box GxP Validation datasheet to learn more