Learn how USDM helped an emerging biotech customer to implement their Veeva RIM Regulatory Submissions Vault to ensure compliant workflows and maximize their IT investment.
Emerging and startup companies typically do not have the IT resources or deep regulatory domain expertise needed to ensure flawless implementation and adoption of their technologies. USDM can help to significantly reduce your implementation and validation time while decreasing the cost to manage cloud compliance. Additionally, we can provide the resources necessary to ensure that your projects are properly managed on time and on budget based on decades of life sciences best practices.
The Situation
- An emerging clinical-stage, Phase 1, biotechnology company
- Less than 150 employees
- The customer was replacing a legacy application and needed support with the implementation and validation of the GxP workflows for their regulatory submission process
- The customer needed continuous cloud compliance support managing Veeva’s regularly scheduled updates and releases
- The customer required a high-performance team and project management services to accelerate and enable commercialization activities
- Additionally, the customer needed Organizational Change Management (OCM) to ensure adoption across the organization
The Solution
- USDM was selected for the project due to our Veeva expertise
- USDM assisted with the implementation and validation of the end-to-end workflows for the regulatory submission process in an accelerated timeline
- USDM managed the customer’s project team to ensure the customer’s regulatory compliance requirements were delivered correctly and on time
- Despite the customer team being displaced due to the COVID-19 remote working mandates, USDM was able to keep all stakeholders aligned
- USDM was also able to pivot quickly and deliver all necessary system training requirements virtually
- Furthermore, USDM provided virtual Organizational Change Management training to the key stakeholders and systems users to drive faster adoption
- USDM achieved end-to-end compliance for the customer’s Veeva Regulatory Submissions Vault implementation and continues to handle the customer’s change management with every Veeva update to ensure continuous compliance
The Results
- Precise execution and implementation for GxP workflows and uses
- On time and on budget despite COVID-19 business continuity disruptions
- Relieved the burden of change management for Veeva updates
Additional Veeva Resources
Webinar: Minimize Risk and Maintain Compliance on Veeva with USDM Cloud Assurance
