Vault QualityDocs

Providing superior ease-of-use and seamless collaboration, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval workflows, and facilitates sharing of GxP documents among employees and partners.

BENEFITS
  • Gaining control of GxP documents: Visibility into content status and processes enables proactive mitigation of issues, effective documentation management, and reduced compliance risk.
  • Greater user adoption: Vault’s intuitive interface means even the occasional user is easily integrated into controlled document processes, and accessing the right document is simple—every time.
  • Increased efficiency: Automated workflows and classification streamlines processes, increasing end user productivity.
  • Audit readiness: Detailed audit trails, content organization, and powerful search facilitates better audits and inspections.
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Manage and Share GxP Controlled Documents in One Place

Monitor in Progress Docs Such as in Approval, Review, or Overdue

Complete Assignments on Time with a Home Page User Task List

Features

COMPLIANCE REPORTING

Visibility into read and understood, periodic review, and other workflows allowing easy reporting of outstanding or upcoming tasks, and mitigating compliance risks.

CONTROLLED CONTENT ACCESS AND COPY DISTRIBUTION

Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. The printed document contains a configurable overlay displaying information such as the person who downloaded it, when it was downloaded, and how long the copy is valid.

COMPREHENSIVE AUDIT TRAIL

Easily demonstrate compliance with detailed audit trails capturing every event in a document’s history, including document approvers and reviewers, status changes, execution of a signature, and more.

ELECTRONIC SIGNATURE AND MANIFESTATION

Approve documents using electronic signatures and manifestations that are compliant with Title 21 CFR Part 11 and EU GMP Annex 11.

INTERACTIVE DASHBOARDS AND REPORTS

Self-service reporting and dashboards enable users to see status of content and processes, making it easy to identify bottlenecks, click through the report for more detail, and share the information with your team and partners.

Learn More Customer Story
DOCUMENT CHANGE CONTROL

Track and control document changes—such as withdrawal, approval of revised content, and release for use, automatically gathering proposed changes and reason for changes to support future audits.

REAL-TIME COLLABORATIVE AUTHORING

Seamless integration between Vault and Microsoft Office Online provides real-time collaborative authoring and does so in a compliant way. See a demo.

QUALITY DOCUMENT TAXONOMY

Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitates operational harmonization, and allows organizations to quickly adopt best practices.

CONFIGURABLE QUALITY WORKFLOWS

Build in compliance with automated quality workflows including document expiration, periodic review notification, and training flags. Easily extend workflows to include quality management systems with our Sparta TrackWise Connector and to learning management systems to enable end-to-end quality processes.

Demos & Videos