Veeva GxP Compliance
Veeva and USDM provide an innovative approach for maintaining GxP compliance in the cloud.
Veeva Vault’s unique ability to manage both content and data in a single platform enables life sciences organizations to quickly deploy powerful applications that manage end-to-end processes with related content, data, and workflows. Coupled with USDM’s Cloud Assurance service, customers can trust that their Veeva applications stay continuously compliant and mitigate risk.
USDM’s industry expertise ensures the program is expertly managed, implemented correctly, and adopted across the organization. Together, USDM and Veeva provide world-class solutions that enable life sciences companies to meet FDA 21 CFR Part 11 and EMA EudraLex Volume 4 Annex 11 regulatory requirements.
How USDM + Veeva can support your business processes
- Fast-track your implementation with senior program management experts who will guide you in pre-implementation work-throughs and end-user training
- Provide your organization with a comprehensive annual vendor audit to save time and effort with your vendor requalification endeavors
- Develop procedures for your Veeva implementations
- Reduce implementation and validation time while decreasing the cost to manage cloud compliance
- Maintain continuous cloud compliance with USDM’s Cloud Assurance subscription for release management
- Develop your business content governance structure and efficiently map to Veeva workflows to company objectives through USDM’s Veeva Center of Excellence managed services
- Leverage critical organizational change management, training, and communications support to ensure your IT investments are successfully adopted
- Use USDM’s Managed Services for continual improvements
Additional Veeva Cloud Services for R&D through Commercialization
Are you planning a Veeva Audit / Supplier Qualification? USDM conducts an annual audit of Veeva, which is included in USDM’s Cloud Assurance solution. This audit can also be purchased individually to help save you time conducting your audit. USDM’s audit standards include:
- Eudralex Vol. 4 GMP; Annex 11: Computerized Systems
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- ISPE GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
- Global Data Privacy Regulation (GDPR)
- ISO 9001:2015 – Quality Management Systems – Requirements
- ISO 27001:2013 – Information Security Management Systems – Requirements
As a Premiere Services Partner of Veeva, USDM can also assist with expert program management, end-user training and communication, data migration, content governance, and post-go-live configuration and change management. Contact us to learn more.
Veeva Validation and Technical Support Managed Services
Without the right help, proper configuration and lack of support services can slow deployment. As a Veeva Premier Services Partner (Development Cloud), we have experience implementing, validating, and maintaining continuous compliance for hundreds of Veeva customers. Our Veeva expertise, longevity, and white-glove services set us apart. USDM offers three types of managed services to support your Veeva environment.
Veeva GxP Managed Services
USDM’s Cloud Assurance subscription covers your annual vendor audit, initial validation, and release management for Veeva’s three releases per year and maintains your continuous Veeva GxP compliance. If you need more extensive post-go-live configuration and change management support, we can customize the right GxP managed services solution for you.
Veeva Technical Managed Services
We also have the technical resources to help you with the configuration changes and enhancements needed after a release goes live to improve performance and productivity and help desk and IT support. We have solutions for internal provisioning, user access, and user administration for troubleshooting Tier 1 and Tier 2 issues.
Veeva Center of Excellence Services
Often, emerging companies don’t have a governance model or continuous improvement framework due to a lack of resources, smaller team sizes, and overwhelming demands to launch a new product. USDM can help you build a vision and framework for leadership roles and responsibilities, global versus regional business functions, and provide an escalation path for making strategic decisions. This includes building a content and data governance model for change management, release management, process harmonization, and data management and creating standardized working methods across your organization. Additionally, we help with continuous monitoring and improvement by establishing, tracking, and analyzing KPIs and establishing processes for configuration change requests or enhancement requests to improve performance.
Read Pharma Tech Outlook’s article on our USDM and Veeva partnership here.