1. What exactly is the Veeva Vault?
Veeva Vault is a cloud-based quality management solution that provides a single, secure application for the management of Quotient documents and quality events. Veeva unifies quality, document and training management applications to automate and harmonize quality processes globally. As a single source of truth, Veeva provides complete visibility and control over quality business processes.
2. What is the backstory or rather the need for Veeva?
Paper-based quality management systems (QMS) inherently present barriers when trying to achieve “right the first time” quality and efficient operations. They are labor intensive to manage, and visibility into quality processes and data is extremely difficult. As a global business, Quotient recognized the importance of moving to an electronic QMS that is easy to maintain, dynamic, and scalable with our future business growth; a system where information is available at all times and provides agility to both Quotient and our customers. Veeva was identified as the best system to further enable Quotient to support our customers in accelerating their molecules through development from candidate selection to commercial product manufacture.
3. If other vendors were considered, why did Quotient ultimately decide to choose Veeva?
Quotient assessed several vendors against our requirements and selected Veeva as the best solution for Quotient to meet current and future business needs. Quotient was impressed with the ease by which the system could be configured, managed and used. Within a single system, we could manage our documents and quality system processes and assure that oversight is maintained through Veeva’s integrated dashboards and reports.
4. What are the benefits from an internal perspective?
Veeva helps everyone stay on task with review, approval, training, and release of documents. Veeva QMS manages a range of quality processes and regulated content. The system functionality provides transparency into Quotient’s quality systems and allows all employees to quickly identify the status of a document or quality event. Automated email notifications help users know when they have assigned tasks or if tasks are overdue for completion. Through Veeva’s integrated reports and dashboards, metrics can be easily monitored by QA and leaders across the business to identify risks, bottlenecks, and promote continuous improvement. These benefits help improve employee efficiency, productivity, and compliance.
5. How will Veeva impact our customer’s experience and will there be any changes in how our customers work with us?
The benefits that Veeva brings to our internal team are also benefits shared with our customers. Veeva will simplify historically complex quality processes and improve our ability to deliver time-to-value for our customers. While there have been some changes to our documents and processes that may be visible to our customers, these changes should not impact how our customers work with us.
Quotient recognizes that one of the benefits of an integrated QMS is the ability to better align with our upstream and downstream business partners and to engage with these partners directly into our quality processes. At the current time, while Quotient continues to learn and leverage system benefits internally, customers will not be asked to interact with Veeva. This functionality will be further explored at a future time.
6. Who has been involved in the Veeva launch and how do their roles play significant part in the success of using the system?
Quotient had assembled a team of quality professionals with representation from all our global sites. Over the course of a year, in collaboration with representatives from Veeva, this team worked to define requirements, configure the system, test, validate, author procedures and work instructions, reformat and migrate documents, set up user accounts, verify integrity of migrated documents, and train all users across the global business. These team members each played a significant role in assuring the successful launch of Veeva.
7. Why is quality so important to Quotient Sciences and how does launching Veeva demonstrate that?
Delivering the highest levels of quality in our products and services to meet customer demands remains a top business priority for Quotient. Our customers put their trust in us to accelerate their drug development and help bring their molecules to patients as fast as possible. To achieve this, we must couple our scientific expertise and understanding of regulatory requirements with agility, transparency, and efficiency. Veeva is the ideal tool to help us meet our customer’s demands and represents a significant investment in quality, compliance, and our customers.
8. What else is important for our customers to know to about the Veeva launch?
Prior to launching Veeva, Quotient successfully completed a comprehensive validation, then migrated documents to Veeva using Veeva’s Vault Loader function. Post-migration, Quotient conducted a verification to confirm that the integrity of documents was maintained throughout the process.
With the implementation of Veeva, Quotient has not changed any processes as it relates to customer document and data confidentiality. The security access granted for all Quotient employees in Veeva is commensurate with the access an employee would have had previously in the legacy system. Any records that require restricted access will not be stored in Veeva.
9. How does the Veeva launch support Quotient’s One Business, One Customer Experience” initiative?
Within Veeva, Quotient has leveraged both internal and industry best practices and established globally harmonized processes for the management and control of documents, deviations, customer complaints, corrective and preventive actions, change control, internal audits, supplier quality management, and continuous improvement initiatives. The harmonization and integration of these systems provide a common platform for customers to work consistently with Quotient across our global business.
10. Anything else that you would like to mention about the Veeva launch before signing off?
Quotient took a phased approach to implementation of Veeva across our global business, with our final site going live on 20 August 2020. Veeva is still a new venture for us and all employees are still learning the system and adapting to this change. We are confident that the system benefits will be quickly realized and Veeva will be an integral business tool for Quotient to accelerate the delivery of high-quality products and services to our customers.