June 7, 2023
On May 20, 2023, UL Solutions released a major platform upgrade to its industry-leading ComplianceWire® learning and qualification management system. A life science-focused software as a service (SaaS), ComplianceWire is among the most widely used software of its kind in the global pharmaceutical and medical device industry.
Mike Lawrence, senior product manager for UL Solutions ComplianceWire, has established a directional vision for priorities. This roadmap has four principal themes:
- Risk-reducing visibility, traceability and control: New and improved non-administrative functionality that increases compliance responsiveness across various user categories in multiple roles
- Audit-ready GxP reporting: New and improved reporting and audit logging to support both internal and external regulatory compliance inspections and audits
- Time-saving administration and ease of use: New and improved administrative functionality and user interface that simplifies the definition and management of client-specific role-based training, qualification and compliance programs
- Value-multiplying flexibility and scalability: New and improved data and workflow integrations with third-party platforms and enhancements to ComplianceWire platform stability, quality, performance and scalability
ComplianceWire’s 2023R1 release — the 53rd major release in its history — delivers significant progress toward fulfilling these long-term goals.
A new dashboard and value-adds to existing dashboards
The highlight of the upgrades and new features included in 2023R1 is a much-anticipated new user group compliance dashboard. Administrators and managers now have direct lines of sight into key compliance and competency measures for their defined groups, helping organizations to stay on top of their compliance and quality requirements.
Additionally, the MyTeam dashboard for managers has undergone multiple enhancements, including renaming it Manager Dashboard. Managers also now have easier menu access with at-a-glance views of the team’s curricula, assignments and completion status.
Enhanced instructor-led learning function
While ComplianceWire previously required learners to sign in to instructor-led, in-person classes using the instructor’s device, a new feature of R12023R1 changes this. With the surge in virtual learning, learners can now register their course completion directly from their own devices. This new functionality helps promote compliance and traceability and also simplifies instructors’ postclass responsibilities.
A facelift for Forms
ComplianceWire’s versatile and powerful Forms feature replaces paper-based processes for out-of-band information capture. With Forms, customers can collect information and apply it to any purpose on the ComplianceWire platform. For example, the Forms feature can integrate on-the-job training (OJT) into the ComplianceWire platform by adding authentication and monitoring, quizzes and assessments, and reporting to OJT.
Additionally, 2023R1 updated the Forms user interface to provide clarity for users and — perhaps more importantly — to establish a framework for future enhancements. Other enhancements include renaming and standardizing labels to offer greater flexibility with signature types.
Beyond feature functionality, reporting is the most critical function of enterprise class software. The ability to deliver a single source of truth is essential, particularly for FDA-regulated companies. The 2023R1 release brings another report to ComplianceWire’s robust assortment of standard report options.
The new Form Incomplete Assignment Status Report by User provides progress updates on incomplete assignments related to Forms that were not visible in the past. You can view the progress of assigned forms based on new statuses displaying which signature a form is waiting on — reducing the risk associated with long-running, multisigner training.
This release also provides additional reporting functionality. ComplianceWire’s Event Log Report now includes events related to adding, editing and removing user groups in addition to numerous other reporting tweaks and value-adds.
Other important new features of this release include:
- Updated User Profile compliance status to be consistent with compliance dashboards
- Allowing an administrator to remove Learner Completions (opt-in)
- Ability to assign multiple users/training items via one-time assignment
- Preventing required assignments from being converted to electives
- Miscellaneous Forms user interface (UI) updates
- Completion page UI enhancements
- Allowing clients to change the default time to send overdue assignment emails by contacting Client Services
UL Solutions ComplianceWire
Developed through a Cooperative Research and Development Agreement between the United States Food and Drug Administration (U.S. FDA) and UL Solutions, ComplianceWire is used in training FDA inspectors and state, local and Tribal inspection partners. Globally, China’s National Medical Products Administration (China NMPA), the Food and Drugs Control Administration for the state of Gujarat in India (Gujarat FDCA), and the Saudi Food and Drug Administration (Saudi FDA) also use ComplianceWire. More than 600 customers and 3.6 million users in 153 countries count on ComplianceWire to develop critical pharmaceutical and medical devices that are safe and effective.
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