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  • Software

ComplianceWire® GxP Training and Qualification Management

Validated, Part 11 compliant learning and qualification management system for life science industries.

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ComplianceWire® is the learning management system (LMS) of record for U.S. Food and Drug Administration (FDA) regulated industries that life science companies have relied upon since 1999. It was built specifically using recognized instructional design principles and expert regulatory experience to meet the stringent regulatory needs of 21 CFR Part 11 validated environments. With over 600 million training completions recorded, this proven technology is used globally by pharmaceutical, medical device and biologics companies, as well as regulatory authorities in the U.S., China and India to deliver the training and proof of qualification required to develop safer and more effective medicines and medical devices. Equip your workforce with the risk management best practices needed to prevent potential corrective and preventative action (CAPA) by the FDA.

  • Natively compliant with 21 CFR Part 11 regulatory requirements
  • Automated, role-based assignment functionality
  • Seamless integration with enterprise-quality software ecosystems
  • Easy dashboard views of organizational risk
  • Powerful ad hoc reporting and over 250 audit-ready standard reports
  • Flexible, unlimited security roles
  • Part 11-compliant electronic signatures
  • Multiple learning assessment options and on‑the‑job training (OJT) support
  • Thirty-four languages available, for both platform and content
  • Distribute your own standard operating procedures (SOPs), videos or SCORM and AICC learning content

Trust the learning and qualification management technology used by the U.S. FDA

Under a unique Cooperative Research and Development Agreement (CRADA), ComplianceWire® and UL Solutions training courses have been used by the FDA to train more than 70,000 global, federal, state and local investigators. The FDA chose ComplianceWire® to help power ORA-U, the FDA’s Office of Regulatory Affairs (ORA) virtual university, to ensure the proficiency of their investigators. ORA-U integrates the ComplianceWire® learning management system with curricula UL Solutions co-developed with the FDA. This same technology platform and coursework are available exclusively to UL Solutions customers.

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Automated, role-based training assignments with flexible security roles

Enables training managers to configure role-based user groups and create automatic assignment rules, ensuring on-going staff compliance and qualification. Administrators can easily define specific security access based on the unique needs of a given role or organization structure (managers, trainers, IT personnel).

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Built-in compliance with 21 CFR Part 11 and EU Annex 11 regulations

ComplianceWire® is built from the ground up in strict compliance with the security, data integrity and audit trail requirements mandated by 21 CFR Part 11 and EU Annex 11 within a fully validated software development life cycle, available for customer audit.

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Secure plug-and-play with any quality system

ComplianceWire® integrates seamlessly with SSO, HRIS, EDMS, clinical trial, ERP, MES and other learning management systems. These integrations can automatically require retraining upon external document revision, ensure user information is synchronized with human resource systems, control access to manufacturing activities based on individual qualification status, and allow for one-click user authentication. 

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Dashboards to assess organizational risk at a glance

ComplianceWire® dashboards provide stakeholders with organization-wide compliance and qualification status using simple and attractive data visualizations. Dashboards can be easily configured to present immediate views into your team’s qualification data to executives or any key personnel in the organization. Dashboards are customizable and interactive and provide both holistic and segmented views of critical data around learning effectiveness, training gaps and organizational compliance.

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Easy, real-time, audit-ready reports

ComplianceWire® provides standard, audit-ready reports with no customization needed. Additionally, the platform provides a custom report tool to generate hundreds of ad-hoc, matrix and qualification reports. Reports can be automatically emailed at any cadence to users, managers or stakeholders in a variety of formats, including Excel, CSV, PDF and printable dashboards. These reporting and analytics tools drive data elements to let executives, managers and administrators identify impacts, trends, progress and results.


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