Veeva QualityOne is a comprehensive, cloud-based Quality, Health, Safety and Environment (QHSE) management software solution that makes it possible to easily and effectively manage document control and training, quality processes, and HSE events in a family of applications. QualityOne simplifies and provides seamless collaboration, tracking, and conformance of the end-to-end quality process through a consistent user experience for all parties. QualityOne is built on Vault and includes the features described in Vault Help for Platform.

QualityOne applications can be used alone or together within a single Vault.

  • Document Control is an application to manage documentation associated with a quality system. It accelerates review and approval workflow, and it facilitates sharing of GxP documents among employees and partners. This document management system provides benefits such as the availability of information, preservation of knowledge, the ability to manage revisions and obsolete documents, visualization of business processes mapped to documents, and streamlining the approval process.
  • QMS (Quality Management System) is an application that manages global quality processes across an organization and its external partners. This quality management system allows organizations to provide consistent quality for products and processes by allowing organizations to standardize requirements, organize and centralize quality process policies, and increase collaboration between users and external partners. QualityOne QMS supports reporting and investigation of Quality events, including identifying root causes using built-in 5 Whys Methodology, assessing criticality or risk level, and managing the complete corrective action (CAR) and the change management (MOC) processes to ensure that Quality risks are controlled. Additionally, you can address food safety needs through the Hazard Analysis and Critical Control Points (HACCP) and the Foreign Supplier Verification Program (FSVP). QualityOne QMS allows organizations the flexibility to customize their Vault according to their adopted quality standards and practices.
  • HSE (Health, Safety, and Environmental) is an application that enables organizations to report, track, investigate and manage health, safety, environmental, vehicle, and property damage incidents that impact workers, business operations, and physical assets. QualityOne HSE also provides risk management functionality to effectively evaluate and manage potential risks associated with operational processes, enabling users to manage Permits to Work, perform HAZOP studies, generate OSHA logs, and more.
  • QualityOne Training is an application that allows customers to create and manage training content and tasks. QualityOne Training currently provides two (2) separate training environment options: a separate Training Vault connected to a QualityOne Vault and Training Management within QualityOne.
    • Training Vault is an application that utilizes a separate Vault to support different training use cases in addition to quality training. This allows organizations to expand, manage, and complete various training material types under a single Vault. The Training Vault connects to the source content from the QualityOne Vault using CrossLink documents that allow content reuse across multiple Vaults. Using Spark messages, organizations can automate a set of rules that map fields from a QualityOne Vault to a Training Vault for training materials.
    • Training Management is an application within QualityOne that manages role-based qualification and training to support job and audit readiness while demonstrating compliance. It gives organizations the tools necessary to deliver the right content to the right learners. Training management optimizes the delivery of training assignments to the appropriate learners, scheduling of various styles of classes, building curriculums and training requirements, and instructor engagement.
  • QualityOne Station Manager is a mobile application for Apple iPadOS devices for viewing quality documents on approved devices on the manufacturing floor. QualityOne Station Manager provides a completely mobile, encrypted experience for viewing QualityOne documents, with fast, offline access 24 x 7.

Shared Features

QualityOne applications share the following common features:

  • Teams: QualityOne enables management of structured teams of individual users that are responsible for completing specific processes within your Vault. As most quality processes are workflow-driven, Teams allows users to be selected as workflow participants when a workflow on a record starts. Assigning roles to team members defines the team that will be involved, keeps a record of who the participants are, and holds each participant accountable for their assigned task.
  • Related Record Automation: QualityOne allows organizations to automate the creation of related records when a source record enters a lifecycle state or during the creation of a source record. This feature also allows Admins to map field values to copy over to the automatically created records, removing the dependency on the user to manually create and populate new records.

The following articles apply to all applications in the QualityOne family:

Admin Articles

The following configuration articles apply to all applications in the QualityOne family: