Enable complete quality document control and GxP compliance

Vault QualityDocs provides a single source for all quality, manufacturing, validation, and other GxP documents and records. The software reduces the burden of GxP compliance by automating and managing document control processes, helping medtech companies maintain high quality standards at all times.

Benefits

Improve Quality and Compliance

Quickly establish good quality practices and facilitate 21 CFR Part 11, Annex 11, GxP, and other regulatory compliance.

Accelerate User Adoption

Intuitive experience drives user adoption and efficiency. Easy access anywhere, anytime, and from any device enables a single system of record

Strengthen Reporting and Metrics

Reporting and metrics identify the state of control, risk, and drives continuous improvement. Robust quality event linkage to content updates and training ensures up-to-date information.

Features

Always Current, Never Stuck

With modern cloud Software-as-a-Service (SaaS), you are always current; you won’t get stuck with an inflexible application that is heavily customized and quickly out-of-date. Veeva MedTech is constantly innovating and validating new releases, so no one gets stuck on an old version.

Read and Understood

Training documents and videos can be delivered easily and cost-effectively for every employee in an organization. With traceability and reporting on all “read and understood” actions, easily track when users view content, sign off on training tasks, or are overdue on activities.

Watermarking and Overlays

Define and apply dynamic overlays and watermarks on a document’s header, footer, or across each page to see the current status or effective date on a procedure or work instruction.

Document Change Control

Users can easily request, review and approve, or reject changes to controlled documents. This flexible feature with predefined workflows and reports tracks and traces all changes through version-aware relationships.

Periodic Review

Quality managers can easily ensure that reviews are started and completed in a timely fashion. The periodic review feature automatically triggers review reminders for documents based on predefined rules, and reports can be generated on the status of review tasks across the organization.

Real-time Collaborative Authoring

Seamless integration between Vault QualityDocs and Microsoft Office Online provides simultaneous authoring for real-time collaboration.

Reports and Dashboards

Time-based reporting lets customers leverage best practice reports, including documents set to expire, documents with upcoming periodic reviews, and more.

Controlled Copies

Get complete control over document copies. Control who can create document copies and take them outside of Vault QualityDocs; track individual document copies’ statuses in the field or during/after revision.

Signature Manifestation

With Vault QualityDoc’s configurable signature page, organizations choose when and how to display the signatory’s name, date, and reason for sign-off, eliminating the need for wet signatures on hard copy documents.

Application Integration

The open, published Vault API easily integrates with complementary systems, such as QMS, LMS, or PLM.

To develop and manufacture products faster, we needed an agile quality solution to easily share and collaborate on SOP and GxP documents. Veeva Vault QualityDocs delivers industry-leading features, from document control to audit trails, that allow us to speed execution throughout our supply chain.

Tim Holden

Director of Business Development and Licensing

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We launched two COVID-19 tests, and having an electronic document control system readily available has been instrumental in getting this done on time. Having visibility into the documents for external auditing enabled us to maintain compliance really well. We have also used it for virtual audits, and having readily accessible documents to show auditors has been great.

Tristin Wolff Cope

Regulatory Compliance Manager

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