This year’s Veeva Summit was a culmination of many key milestones for quality. The Veeva Vault Quality community, comprised of quality professionals from life sciences companies, previewed its first position paper, “Risk-based Approach to Change Management of Validated GxP Systems.” A working group of six community members, led by Sean Smith from Blueprint Medicines, proposes a risk-based approach to streamlining GxP system configuration changes and release updates – without compromising the quality of the “system product” or the integrity of the validated state. While the scope of the paper focuses on Veeva Vault QualityDocs, the principles and methodology can be applied to a wide range of GxP systems and aligns with ICH Q7, ICH Q9, ICH Q10, and GAMP 5. Numerous companies are investigating, or in the process of implementing, risk-based processes and were thrilled to get a first look at the position paper. It will be widely available in mid-November – please register here for a copy.
Applications that do not work well together and fragmented processes have always plagued quality organizations. Ionis’ presentation discusses how it was difficult for users to traverse between separate QMS and content management solutions. Creating new processes in the legacy QMS system was also challenging. Moving to a unified quality suite that is easy to use and administer provides a superior user experience and enables Ionis to keep up with new business requirements. Veeva Vault QMS was launched just over a year ago and companies are seeing the benefits of it working seamlessly with Veeva Vault QualityDocs – driving rapid growth in the Veeva Vault Quality Suite. Ionis joins more than 30 of the 120 Vault Quality Suite customers that own Vault QMS – with many of them deploying or having deployed Vault QualityDocs.
Keeping employees trained so they can perform their jobs at the highest level of proficiency is also crucial to quality. UL presented a case study on Insmed. By leveraging the UL connector to integrate ComplianceWire, a LMS solution, with Vault QualityDocs, Insmed improved inspection readiness, learner retention, and employee performance.
As companies outsource critical functions, they need to work closely with partners to maintain quality oversight. Companies, such as Gilead and Karyopharm, are directly incorporating partners into quality workflows – improving data integrity, accelerating cycles times for processes including lot disposition, and keeping vendors informed on current policies and procedures. There are now over 100 contract manufacturers, test labs, and other partners that leverage Vault QualityDocs to send data and documents, or stay up-to-date on contractor manual changes. A chronological audit trail of who sent, reviewed, or accepted the data or content is captured for audits and inspections. The information can also be leveraged to track partner performance and help both parties achieve common goals. With Vault QMS, pharma companies will be expanding access to partners and allowing them to directly respond to audits, or enter deviations and corrective and preventive actions (CAPAs) – gaining real-time visibility.
Processes such as change control require orchestration of event or time-driven tasks across many different parties. Multiple customer presentations, including “The Future of Quality Management” customer panel, echoed that there are significant opportunities for streamlining cross-functional processes. The Veeva Vault Development Cloud provides a technology foundation for drug development, and is gaining momentum. For example, with the Vault Quality and Vault RIM suites, companies can manage the change management process from the beginning where regulatory insight is needed by the quality team for decision-making, to downstream document and regulatory changes, and finally determining shipping decisions based on regulatory approvals – all on a single platform. Hopefully, next year we will see presentations on how customers are leveraging the Vault Development Cloud to drive more efficient end-to-end processes. Mark your calendars for September 18-20, 2018 at the Philadelphia Convention Center. Hope to see you there!