RegulatoryOne Compliance Management Overview

Vault 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.

Vault Compliance Management is part of the Vault 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 Vault and includes the features described in Vault Help for Platform. In addition, it provides the following features:

  • Manage regulatory requests: Compliance Management provides the 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 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 Qualitative 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 data from completed questionnaires into Qualitative Assessments based on Admin-defined mappings.
  • 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.

Data Model

Compliance Management shares some common data model components with other RegulatoryOne applications, which allows you to consolidate data for all of these applications in a single Vault. This is not a complete list of all Compliance Management objects but provides some explanation of important core objects in the data model.

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

Key Objects

In addition to the shared RegulatoryOne data model, the Compliance Management application has additional objects to house data. This is a list of core Compliance Management objects, but it does not include all objects:

  • Regulatory Request: This object represents a request for information related to the regulatory compliance of a product or formulation.
  • Regulatory Request Formulation: This object joins the Regulatory Request and Formulation objects.
  • Registration: This object represents proof that validates clearance in a state, country, region, and by Third-Party Certification or Retailer.
  • Regulated Category: This object represents a registration category for a location, such as “Cosmetic” or “OTC”.
  • Qualitative Assessment: This object represents the compliance status of a formulation’s regulated category.
  • Quantitative Assessment: This object represents the assessment status of a substance’s concentration in relation to its intended use in a given location.

Best Practices

We recommend associating each raw material Formulation with no more than one (1) supplier Organization. This allows regulatory teams to assess each material in terms of a specific supplier and account for variations such as impurity profiles and total concentrations of constituents.

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

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