Medical Devices, Pharmaceuticals, Health Care

ComplianceWire - Manage GxP Qualifications

Life Sciences companies can rely on the UL Enterprise LMS for both GxP and non-GxP activities within a single interface. The ComplianceWire engine within the UL Enterprise LMS enables Life Sciences companies to manage education and qualifications for the GxP workforce, as it meets the stringent demands of 21 CFR Part 11 and Annex 11, and enables learning and compliance teams to manage role-based qualifications within operations, clinical, quality labs and other GxP areas. ComplianceWire recorded nearly 42 million training completions in 2016, serving users in more than 100 countries.


If you are an existing ComplianceWire user, visit to login, or contact your local administrator for details.


Benefits of the ComplianceWire engine include:


  • Automation that Reduces Administration Costs: Automate the identification and delivery of education and qualification requirements for all employee roles an employee - and continue to maintain that automation through employee role changes, training requirement changes, and training material revisions - companies can reduce administrative costs by 40% or more;


  • Organize Multiple Knowledge Assets: innovative role-based learning path functionality enables curricula owners to collect relevant SOPs, classroom events, mentoring activities, onlne training assets, self-assessments, and much more into a role-based qualification curriculum, improving knowledge management and business processes;


  • Assessment Tools to Demonstrate Training Effectiveness: Quiz and assessment tools eliminate paper-based processes, as qualified personnel can record on-the-job observations that are stored with each employee's transcript, as part of an audit reports presented during regulatory inspections (US FDA, EMA, CFDA) to demonstrate qualification and training effectiveness;


  • Reduced Validation Effort to Maintain 21 CFR Part 11 Compliance: Validation teams can eliminate the IQ and OQ effort, and minimize the PQ effort, through UL test scripts and adherence to electronic record-keeping requirementsIntegration with HRIS, DMS (such as Veeva LMS), MES and CTMS: improves accuracy of data being fed, ensures workflow of operator certification programs, and reduces risks associated with manual updating of new user attributes or updated with the latest materials.