RegulatoryOne Compliance Management Overview

Veeva RegulatoryOne Compliance Management is an application that helps users manage and complete regulatory requests and track responses. Regulatory Affairs users can respond quickly and confidently to the volume of external requests from regulated authorities, CROs, customers, and suppliers, as well as internal requests from sales and R&D. Compliance Management allows users to access accurate and complete information and documents from a centralized place.

Compliance Management is part of the Veeva RegulatoryOne family of applications. Within a single Vault, your organization can have one (1), two (2), or all of these applications.

Compliance Management Features

RegulatoryOne Compliance Management is built on Veeva Vault and includes the features described in Veeva Vault Help for Platform. In addition, it provides the following features:

  • Manage regulatory requests: Compliance Management provides users with the ability to mitigate non-compliance risks by accessing accurate, up-to-date, and consistent information to include in responses to requests for information related to the regulatory compliance of a product or formulation. For each request, users can quickly create a request from predefined types, add relevant details, and then submit for review. Regulatory users can provide responses, associate related documents, view similar requests to ensure consistency in responses, and create any required secondary requests.
  • Manage formulation composition compliance: Compliance Management provides users with the ability to visualize a formulation composition in a hierarchical viewer, to easily ensure that all constituent chemicals are compliant in a given market before approving the composition for use by your organization. Users can review and manage assessments directly in the viewer.
  • Manage formulation questionnaires: Compliance Management provides users with the ability to send targeted questionnaires to respondents, such as suppliers, and the ability for those respondents to complete questionnaires securely, without logging into a Vault. Users can import attachments to your Vault Library and import data from completed questionnaires into Qualitative Assessments.
  • Manage quantitative assessments: Compliance Management provides users with the ability to compare the total concentration of substances in a formula to restrictions in a given market, allowing them to determine if a formulation is compliant early in the product development lifecycle. Users can also automatically create Quantitative Assessments for substances of concern in a specific formula.
  • Manage packaging composition compliance: Compliance Management provides users with the ability to visualize a package’s composition in a hierarchical viewer to review the weight and percentage of its recycled content. Users can review and manage assessments directly in the viewer.

Learn more about using the Compliance Management application in these articles:

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