QualityOne Document Control Overview

QualityOne Document Control is an application that manages documentation associated with a quality system, providing seamless collaboration, reducing compliance risk, and improving quality processes. It accelerates review and approval workflows, and facilitates sharing of GxP documents among employees and partners. The Document Control solution primarily interacts with documents and document types.

QualityOne Document Control is part of the Veeva QualityOne family of applications. With a single Vault, your organization can have one (1), two (2), or all of these applications.

Features

QualityOne Document Control is built on Vault and includes the features described in Vault Help for Platform. In addition, it provides the following features:

  • Document Change Control: QualityOne Document Control enables tracking of documentation, specifications, and processes to ensure users have correct and up-to-date versions. Efficient document control and document control processes are an essential part of compliance requirements for companies operating in GxP and ISO (such as 9001 or 14000) environments, as well as in regulated industries. You can use document lifecycles and workflows to automate common Quality document processes such as Draft to Effective.
  • Controlled Copies: QualityOne Document Control allows companies to manage controlled copy generation, distribution, and tracking. It allows security-governed users to generate numbered copies of content for use by contract organizations or facilities which lack access to your Vault. In legacy controlled copy configurations, you can report on controlled copies and track their status (for instance, in recall or recall confirmed) using Distribution type reports. In Vaults using Extensible Controlled Copy, you can configure specific controlled copy types, security, and lifecycles to collect, manage, and report on detailed data for each type of downloaded controlled copy.
  • Process Hierarchy page QualityOne Document Control allows users to view business processes tied to documents in a visually hierarchical interface. Admins create and manage the structure of the Hierarchy for users to easily navigate to their processes and documents. Your organization can define the business process hierarchies using a standard data model.
  • External Collaboration for Document Review & Approval: QualityOne Document Control allows users to grant temporary task-based access to External Collaborators for document review and approval. Admins can configure Vault to automate the creation or activation of an external user account when a user assigns an External Collaborator to a task, configure customized welcome messages, and define when Vault automatically deactivates the account.

Data Model

Document Control shares some common data model components with other QualityOne applications which allows you to consolidate data for all of these applications in a single Vault. This is not a complete list of all Document Control objects but provides some explanation of important core objects in the data model. Admins can generate a Vault Configuration Report to see all objects in the Vault.

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

Document Change Control Key Objects

  • Document Change Control: Controls the change process when a Change Manager links a Document Change Control record to one (1) or more documents.
  • Document Change Request: Tracks changes seen on a document.
  • Product: Stores the master data and allows reuse and searching of that data across multiple products and documents.
  • Country/Facility/Department: Allow for differing approval processes globally and across many business units.

Extensible Controlled Copies Key Objects

  • Controlled Copy User Input: Captures information from the consumer who requests to download a controlled copy.
  • Controlled Copy Trace: Stores trace records for all controlled copy files generated for the user’s Vault.

Process Hierarchy Key Objects

  • Visual Hierarchy: Defines business-level metadata for a given Hierarchy, including Visual Hierarchy records and their parent-child relationships.
  • Hierarchy Document: Represents the join between Visual Hierarchy records and their associated documents.

External Collaboration Key Objects

  • Ext Collab Document Assignment: Manages document assignments for External Collaborator document review and approval.
  • Organization: Manages information about which organizations are authorized for external collaboration and can be used in conjunction with the Person object to manage a list of eligible External Collaborators (Persons) in an organization.
  • Person: In External Collaboration, stores information about potential External Collaborators.

Learn more about using the QualityOne Document Control application in these articles:

Admin Articles

Learn about configuring the Document Control application in these articles: