ComplianceWire® GxP Training and Qualification Management for Life Sciences

A comprehensive approach to regulatory compliance, ComplianceWire^® integrates the critical components of learning, qualification guidance, content and professional support

ComplianceWire® offers:

Globally recognized learning and compliance technology that helps to enable the creation, automation, and delivery of effective, efficient, high-quality and engaging training programs while reducing training costs.
Library of knowledge/content assets, including more than 1,000 e-learning training modules, organized into catalogs of over 400 life science specific courses, including 110 courses developed jointly by the U.S. Food and Drug Administration (FDA) and UL Solutions.
Customization of knowledge/content allowing changes to our existing courseware or creation of your own courseware to ensure the training components selected are right for your needs.
Prompt, personalized support delivered by expert training professionals.

Validated, Part 11 compliant learning and compliance management system for regulated industries

ComplianceWire️^® is the industry-leading training learning management system (LMS) for compliance and qualification management specializing in life sciences organizations and is compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. This proven technology is used globally by pharmaceutical, medical device and biologics companies as well as global regulatory authorities in the U.S., China, Brazil and India to promote public health through training related to the development of safe and effective medicines and medical devices.

Help ensure compliance with regulatory bodies worldwide

Benefits of our comprehensive regulatory compliance training offering can help bring medical device and pharmaceutical products to market safely:

Assignment-based training functionality — Enables training managers to define role-based qualification groups, with automated group membership and assignment rules to ensure staff receives training that is appropriate to their job function per regulatory requirements.

Flexible security roles — Administrators can strictly deﬁne speciﬁc security access based on the unique needs of a given role (managers, trainers, IT personnel).

Traceability with electronic signatures on assessments and standard operating procedures (SOPs) — Electronic signatures comprised of the signer information, including the first name, last name, and user ID within the system, as required on electronic records per 21 CFR Part 11 and EU Annex 11.

Real-time reports for managers and administrators — Generate, customize and schedule your training, compliance and administrative reports in support of your qualification-based life sciences training program.

Audit trails — Provides more than 250 audit trails, or log events, that capture the time stamp of when the activity occurred. Life sciences companies should maintain log events for many critical activities for audit purposes.

Role-based assignment functionality — Designed to support the creation of role-based groups and assignments to these groups. This dramatically reduces reliance on manual administrative reviews to identify who has the qualification for a speciﬁc role.

Secure integrations with essential enterprise systems — Integrates with document management systems, human resource management systems, manufacturing execution systems and single single-on providers to aid with streamlining your processes.

Version control of training items — Supports proper standard operating procedure (SOP) management and the versioning and retention rules that accompany each SOP.

Multilingual training support — ComplianceWire^® supports 34 languages and has unique multilingual training items for easy management of global training needs.

Learning assessment and on-the-job training support — ComplianceWire^®’s Quic Creator and unique forms features allow for the capture of on-the-job training, surveys, questionnaires and exams to help facilitate learning effectiveness.

Visibility into training status — Data structure and functionality of ComplianceWire^® automates required qualiﬁcation for all employees engaged in GxP initiatives.

Course creation and customization to address unique training needs — Easily modify existing courses or create new courses with UL Solutions Create™ tool.

The learning management technology used by the FDA

Since 1999, ComplianceWire^® and UL Solutions life science e-learning courses have been the FDA’s trusted learning tool to train more than 40,000 global, federal, state and local investigators. The agency chose the ComplianceWire^® platform as part of their training tool, ORA-U, the virtual university for FDA’s Office of Regulatory Affairs (ORA) infrastructure, to ensure the proficiency of their investigators under a unique cooperative research and development agreement (CRADA). This service integrates the ComplianceWire^® web-based platform with curricula UL Solutions co-developed with the FDA.

This same technology platform and coursework used by the FDA to train its inspectors and investigators in its virtual university are available exclusively to UL Solutions customers.

Compliant with 21 CFR Part 11 and EU Annex 11 validation requirements

As part of each implementation, customers receive validation summary reports, Part 11 white papers, an audit with our quality team and validation test scripts. Employees can be automatically sorted into training groups based on criteria such as job function, effectively governing the role-based training process. Automated version control lowers the risk of human error from manually performing multiple version reconciliations and updating a library of constantly changing SOPs.

UL Solutions’ extensive content libraries of life sciences-focused computer-based training courses

UL Solutions is the only LMS provider offering more than 400 standard regulatory and performance-focused course topics. These include, but are not limited to:

Good manufacturing practices (GMP) and quality.
FDA inspections and enforcement.
Good clinical practices (GCP).
Employee health and safety (EHS).
Ethics and corporate responsibilities.
HR compliance and risk management.
Sales and marketing.
Data integrity.

Backed by life sciences online training content

ComplianceWire^® is built to support AICC and SCORM learning content. Our professional development education training courses carefully target the diverse needs of learners, regardless of industry, language, culture or education. This training resource includes:

More than 1,400 comprehensive and updated courses on compliance, safety and healthcare, including more than 110 co-developed with the FDA.
Standardized courses on issues regulated by federal agencies, including the Office of Inspector General, Securities and Exchange Commission, the U.S. Environmental Protection Agency, Occupational Safety and Health Administration, and the U.S. Department of Health and Human Services.
Curricula focused on critical workplace subjects ranging from employee confidentiality to sexual harassment, site security, health and safety, and data integrity.
Professional instructional designers who can work with or for you to design innovative, engaging and effective content customization or make new training content through our course self-authoring tool, Create™.

The Create™ tool can help you with your unique learning requirements

Create is our authoring tool that makes it easy for you to efficiently create and publish new e-learning content for your work force. You can use this tool to edit existing UL Solutions courses or to develop your own.

With Create, you can easily: