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ComplianceWire

ComplianceWire is a globally recognized, cloud-based Learning Management System (LMS) primarily developed and operated by UL solutions. This proven technology is used globally by pharmaceutical, medical device and biologics companies, to promote public health through training related to the development of safe and effective medicines and medical devices. It offers robust, validated training solutions that align with FDA and global regulatory standards like 21CFR Part 11 and EU Annex 11 Validation requirements. It helps to manage and track employee training, ensure regulatory compliance, and streamline quality processes by providing a centralized platform for delivering, tracking, and reporting on training activities. ComplianceWire built specifically to support GxP compliance, it helps organizations automate employee training, manage qualification programs, and maintain audit-ready records with features such as electronic signatures, role-based training paths, audit trials, and comprehensive reporting.

Our ComplianceWire Support Services Include:

  • LMS Implementation & Configuration: We assist in the initial setup and configuration of ComplianceWire to align with your organizational structure, compliance requirements, and SOPs.
  • Custom Training Content Development: Our team creates engaging, SCORM-compliant learning modules tailored to your SOPs, policies, and regulatory needs.
  • Ongoing LMS Administration: From user management to training assignments and reporting, we handle the day-to-day administration so you can focus on your core operations.
  • Reporting & Audit Readiness: We help configure dashboards and deliver custom reports to always maintain complete visibility and audit readiness.
  • User Training & Helpdesk Support: Empower your team with onboarding, administrator training, and ongoing user support for smooth platform adoption.

  • Features of ComplianceWire

  • Training Management
  • Role Based, Automated Training Assignments
  • Extensive Reporting & Audit Readiness
  • Security, Validation & Regulatory Compliance
  • Global / Multi Language Training
  • Centralized Content Library
  • Integrations with Other Systems

  • Best Practices for ComplianceWire Implementation:

    System Setup & Landscape Design:
  • Define roles, user groups and organizational hierarchy clearly.
  • Configure training curricula and certification paths to align with business and compliance needs.
  • Ensure integration with HR systems for automatic user data synchronization.

  • Training Content Strategy:
  • Upload only validated and approved training materials like SOPs, e-learning modules and policies.
  • Map training to job roles for targeted learning.
  • Regular review and update content to maintain compliance.

  • Compliance &Data Management:
  • Maintain accurate user training records for regulatory inspections.
  • Use data archiving and retention policies to manage system load
  • Conduct periodic system audit to verify data integrity.

  • User Adoption & Continuous Improvement:
  • Provide comprehensive onboarding and training for employees and administrators.
  • Monitor training completion rates and compliance gaps through dashboards
  • Encourage feedback from users to improve training effectiveness
  • Continuously update processes to align with evolving regulations and business needs.

  • System Integration:
  • Seamlessly integrate ComplianceWire with HRIS, EDMS and other enterprise systems
  • Facilitate bulk data uploads, historical data migration, and automated data transfer
  • Use REST APIs for data exchange with third-party applications.
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