Veeva QMS Features Brief

Modernizing Quality Management

Greater regulatory scrutiny and the growth of global outsourcing have made quality management complex. Most life sciences companies are using legacy systems that are not designed for collaborating with external partners, such as contract manufacturers and suppliers.

Further complicating quality management, there are often separate solutions for managing controlled processes and regulated content. Even for a simple corrective and preventive action (CAPA) that generates a change control requiring document modifications, content workflows are managed independently from quality processes. This gap between systems creates risk and manual overhead.

Veeva QMS is a cloud-based quality management solution that provides best practice processes for deviations, internal and external audits, complaints, lab investigations, change controls, CAPAs, quality risk management (QRM), and proactive management initiatives. With a modern, easy-to-use web interface, Vault QMS drives higher user adoption with minimal ongoing support.

Business Benefits

• Better align with partners.
  Easily bring departments, sites, suppliers, contact manufacturers, contract test labs, and other partners into continuous quality improvement processes.

• Gain complete visibility into quality processes.
  Track quality processes proactively with the right level of visibility to support timely decisions and accelerate cycle times.

• Greater compliance.
  Ensure global with seamlessly connected and controlled processes that are part of the Vault platform of applications.

• Rapid time-to-value.
  Leverage a ready-to-use, scalable application with built-in best practices and automated workflows to improve operational efficiency in record time.

Features

• Delivered Quality Processes
  Rapidly deploy delivered quality processes for proactive management initiatives, deviations, internal and external audits, complaints, lab investigations, change control, quality risk management, and CAPA processes.

• Application Integration
  The open, published Vault API easily allows integration with complementary applications, such as enterprise resource planning (ERP), or laboratory information management (LIMS) for streamlining processes across business systems.

• Intuitive interface
  Drive high user adoption with an easy to use application. Providing a consumer experience streamlines tasks, and reduces training time and support-boosting productivity.

• Supplier Access and Visibility
  Easily provide access to suppliers and contract manufacturers, integrating partners into key processes for greater visibility and control.

• Configurable Forms and Workflows
  Using 'point and click' configuration, modify best practice workflows or create new processes. End users can quickly add tasks and link documents to a process.

• Mobile Solution
  Effortlessly use the QMS application on any device, from anywhere. Easily check status, complete tasks, or fill out forms while away from your desk.

• Robust Audit Trails
  Annex 11 and 22 CFR Part 11 compliant audit trails that capture every event in a process, including execution of a signature, task creation and assignment, and more.



• Reports and Dashboards
  Gain actionable insights into quality events through selfserve reports showing information on different processes, including deviation, investigation, complaint, audits, CAPA actions, and more. Easily share information with the team and external partners.

• Unified Risk Management
  Easily incorporate risk management into existing quality processes across R&D and manufacturing. Effectively allocate resources with an enterprise-wide inventory of prioritized risks.

• Document Control
  Automatically trigger a document change control for impacted SOPs, work instructions, or other content in Vault QualityDocs—seamlessly connecting quality processes to critical documentation. Users can easily check status and ensure tasks are complete.

Veeva Quality Cloud

Veeva Quality Cloud enables the management quality events from event origination to changing controlled content and completing training on a single cloud-based platform. Connecting quality processes, critical documentation, and training—with Veeva QMS, Veeva QualityDocs, and Veeva Training—accelerates and streamlines event identification, correction, and change management. This end-to-end visibility equips organizations to respond to quality events faster, and provides a complete picture of quality management activities to regulators.