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ComplianceWire: Manage GxP Qualifications

ComplianceWire LMS

ComplianceWire is the premier cloud-based Learning Management System (LMS) for the Life Sciences industry.


Designed to meet strict 21 CFR Part 11 and EU Annex 11 requirements for electronic recordkeeping, ComplianceWire recorded nearly 42 million training completions in 2016, serving users in more than 100 countries.


ComplianceWire clients gain these benefits:


  • 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


  • Management Visibility for Resource Planning: Each employee's role-based qualification status is defined and tracked for manufacturing resource planning


  • Organize Multiple Knowledge Assets: innovative role-based learning path functionality enables curricula owners to collect relevant SOPs, classroom events, mentoring activities, online 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 requirements


  • Simplified End User Interface: each user gains an easy-to-navigate, personalized qualification page that they can access via a web browser, which improves user adoption and satisfaction


  • Integration with HRIS, DMS, 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


  • Improve Quality & Profitability: Operations can improve the qualifications of individuals to realize productivity gains, while QA can demonstrate that these qualifications have improved quality metrics, such as first pass yield, nonconformities, etc.


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