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UL Solutions ComplianceWire® Rolls Out Enhanced Features for Life Sciences GxP Training and Qualification Management

New and upgraded learning management and training features to support pharmaceutical, medical device and biotechnology companies

Clinical data and post-market compliance under the MDR

November 16, 2022

UL Solutions ComplianceWire® has launched a new release of its training and qualification management system that includes several enhancements and improvements to greatly improve and automate GxP compliance in life sciences.

The ComplianceWire® 2022R2 Release features new customizable qualification, compliance and completion dashboards as well as upgraded and expanded reporting tools to help pharmaceutical, medical device and combination product manufacturers manage their regulatory compliance and employee training processes.

New dashboards in Learner’s View

Online Learning as we know it has seen a remarkable shift in the past few years, resulting in managers needing to efficiently monitor and measure their teams’ learning progress and understand skill gaps. ComplianceWire® now includes the new Dashboards feature in the Learner’s View to provide managers an at-a-glance view into their entire teams’ hierarchies. The visual data representation in Dashboards includes a new curriculum qualification chart in addition to the existing incomplete assignment and on-time completion statuses.

Previously, managers had limited visibility to analyze their entire teams’ qualification and compliance status, or depended on administrators to generate the desired report(s). Managers now have access to customizable options that offer the flexibility to include their entire team hierarchy in the data analysis, or have a more compact view covering just themselves and their direct reports.

Some of the functions of the new Dashboard include the following:

  • Select a Chart to view the corresponding summary rollup or a detailed listing in the Data Table.
  • Drill down within the extended team hierarchy (when included) by clicking on users in the Data Table.
  • Drill down to view an individual team member’s curricula, incomplete assignments, and on-time completion status.

Enhanced reporting capabilities

ComplianceWire® continues to develop new reports and enhance our Reporting features to support ease of Audit, Administration, and Integration.

The new User History Report is a tabular report that provides visibility and traceability of user attribute changes which may be used to determine user group membership and assignments. The new report can also track changes made from Human Resources Management System (HRMS) integrations.

Additional improvements

Along with the new Dashboard feature and enhanced reporting tools, ComplianceWire® 2022R2 includes various User Group-related improvements:

  • Upgrades to the User Group entity User Interface (UI) to improve user experience in platform administration. As part of our larger effort to improve data visibility, the upgraded UI Is designed to draw the eye to important data and provide visual cues to user count membership across the group hierarchy.
  • User Groups provide a flexible way to group individuals based on specific criteria, allowing for role-based qualification and compliance automation. Managing users efficiently supports efficient training administration so that only the appropriate users have access to particular data. To expand the criteria selection for a User Group, we have included the following new criteria to allow Administrators to group by security roles, location, etc. These new criteria are reflected in the Criteria Change Log UI, User Group Criteria Report, and Upload Tool for User Group Criteria:
     
    • Security Role
    • Personnel Code
    • User Email
    • City
    • State
    • Country
    • Zip/Postal Code
       
  • To help track changes made to the User Group membership, clear messaging related to an action helps trace historical information about the entity. With improved messaging of the User Group membership history, Administrators can quickly understand the changes impacted by an action, such as adding or removing a user to/from a group via a smart rule, thus saving a few extra clicks to track the changes.
  • Ability to remove Elective Assignments for better administrative control and tracking. Administrators no longer have to instruct individual learners how to remove previously required, now elective assignments; they can now do it directly with no learner involvement.
  • Access to Proxy Schedule from the User Profile to be better informed of the Proxy Manager delegations.
  • Improved security for managing Domain Associations of Instructor Led Classes.
  • Enhanced Single Sign-On (SSO) Support that will allow clients to use multiple Identity Providers IdPs simultaneously, User Provisioning using Azure, including multi-tenant and IdP-hosted custom pages via SSO using Azure. 

Additional ComplianceWire® resources to support life sciences professionals:

  • UL ComplianceWire® LMS support for life sciences companies and manufacturers
  • UL ComplianceWire® Emergency Use Qualification for vaccine producers and developers
  • News story: ComplianceWire reaches 500 million training completions