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.

  • 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. Within this application, you can also manage HSE Incidents to enable organizations to report, track, investigate, and manage health, safety, environmental, vehicle, and property damage incidents that impact workers, business operations, and physical assets. QualityOne QMS supports reporting and investigation of Quality and HSE events, including identifying root causes using built-in 5 Whys Methodology, assessing criticality or risk level, the complete corrective action (CAR) process, and the change management (MOC) process to ensure that Quality and HSE 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.
  • 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.
  • Training Management is an application 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 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; keeping a record of who the participants are and also holding 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.

Shared Data Model

QualityOne applications share some common objects, which allows you to consolidate data for all of these applications in one (1) Vault. Admins can generate a Vault Configuration Report to see all objects in your Vault.

Depending on your Vault’s configuration, object labels may appear differently than the labels mentioned in this article.

Key Shared Objects

This is not a complete list of all QualityOne objects but provides some explanation of some important shared objects in the data model.

  • Product: Contains all information regarding a product, including the product type, specification group, version information, and a reference to the Formulation object.
  • Product Composition: A many-to-many self-reference to Product, contains the composition that makes up a product.
  • Formulation: Contains the information regarding a formulation, including version information for the formulation.
  • Formulation Composition: A many-to-many self-reference to Formulation, contains the composition that makes up a formula.
  • Packaging: Contains the information regarding packaging, including the specification group and version information for the packaging.
  • Packaging Composition: A many-to-many self-reference to Packaging, contains the composition that makes up a package.
  • Product Packaging: Contains information regarding the product’s packaging.
  • Product Batch: Contains information regarding the product’s manufacturing date, expiry date, and batch code.
  • Material: Contains all the information regarding a material, product, formulation, and packaging.

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: