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Home · Resources ·

R&D Demo Center

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Vault QualityDocs

Consistent audit trail, pervasive access and breakthrough usability.
Watch how Vault QualityDocs lets teams simply and securely manage controlled documents through the entire GxP life cycle – from creation through review and approval, and beyond.

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Home · R&D Solutions · Vault QualityDocs

Take Control
Boost Compliance

Making it easy to collaborate, manage, and securely access the right GxP controlled document – every time.


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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.
View Demo

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

02
“Vault QualityDocs has made immediate impact on our operational efficiency and compliance.”
Cindy Luchetti | Vice President for Regulatory and Quality, Conatus
Find Out How
“Veeva Vault delivered on all fronts and was validation-ready, which makes my life much easier. Feedback has been very positive.”
Renee Fate | Senior Manager, Document Management, Kythera
Find Out How
“…more productive in the last six months than the entire year before that.”
Kevin Loftus | QA Manager, Medicines360
Find Out How
“Vault makes us more productive by giving us the ability to use iPads and other mobile devices to securely access controlled documents in the cloud from any place.”
Andy Katz, PhD | COO, GenomeDx
Find Out How
“We’ve been able to harmonize globally … a single system so that processes and document templates can be standardized. This reduces the risk of making errors or duplicating efforts…”
Cara Weyker | Vice President of CMC Regulatory and Quality, Horizon
Find Out How
“Vault is strengthening our compliance and streamlining document management across the enterprise.”
Nobuo Nakamura | President, CMIC
Find Out How
“Vault provides the flexibility we need to be agile and move quickly as our organization and our markets change.”
Malika Mir | Chief Information Officer, Ipsen
Find Out How
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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 Annex 11.

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.

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.

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.

Resources

Webinar

GenomeDx Speeds Content Review to Under Eight Weeks

Article

One Step Back, Two Steps Forward to Improved Quality Processes

Product Brief

Easily Manage, Share, and Collaborate on GxP Controlled Documents

View More Resources

Demos & Videos

Take Control of Your GxP Documents

Scaling with Control and Compliance

Simplify Role-based Readiness

Extending Quality Processes to your Global Workforce

Strengthening Quality Processes with Document Control

Extending Quality Processes Across the Organization

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View Demos
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