Compliance Management for Life Sciences
Learning Technology Chosen by the FDA and Trusted by Industry Leaders
ComplianceWire®, the best-in-class solution for regulated industries, is a powerful, Part 11 compliant and fully validated LMS relied on by Pharmaceutical, Medical Device and Biologics companies to help improve productivity and reduce risk. ComplianceWire is the same platform chosen by the FDA to train more than 36,000 global, federal, state and local investigators.
The Agency chose the ComplianceWire Platform to as their training solution to ensure the proficiency of their investigators under a unique Cooperative Research and Development Agreement (CRADA). This solution integrates the ComplianceWire web-based Platform with curriculum we co-develop with the FDA. The same technology Platform and coursework used by the FDA in its virtual university are available exclusively to UL’s customers.
Powerful, Part 11 Compliant and Fully Validated
Hundreds of Pharmaceutical, Medical Device and Biologic companies rely on UL’s technologies, curriculum and services every day. Our comprehensive compliance training solution integrates three critical components:
- ComplianceWire, a robust and scalable Learning Management System (LMS) on the UL Platform that facilitates the management of training activities, learner proficiency and compliance status.
- Knowledge assets that include a standard library of more than 450 Life Science courses, including 110 developed by the FDA and UL, as well as custom coursework created for individual companies.
- Professional service teams that assist customers by assessing organizational and infrastructure needs, ensuring the seamless integration of your compliance management solution.
Focused on Validation, 21 CFR Part 11 Quality
ComplianceWire is a fully-validated knowledge and LMS that ensures compliance with 21 CFR Part 11 requirements. Equally valuable to Life Sciences companies, it supports the quality and validation constructs defined by Good Automated Manufacturing Processes (GAMPs) and GxPs, including:
- Electronic signatures and records
- Audit logs
- Record versioning
- Data security
- Fully documented Software Development Life Cycle (SDLC)
- Quality systems
UL’s learning resources are developed through our relationships with the FDA and nationally-recognized subject matter experts with experience in Life Sciences research and development, manufacturing, clinical operations, compliance, training and business operations. Our courses target the diverse needs of learners regardless of language, culture or education, and include:
- FDA-authored and/or reviewed courses identical to those used by the FDA to train its inspectors and investigators.
- Standardized courses on issues regulated by federal agencies including the OIG, SEC, EPA, OSHA and HHS.
- Curricula focused on workplace subjects ranging from employee confidentiality to sexual harassment, site security, health and safety.
- Customized, company-specific courses including Codes of Conduct, reinforcement of corporate culture and issues related to specific drugs or devices.
Manage Creation and Distribution of SOPs
Our widely used Critical Information Control System© (CICS) enables companies to manage the distribution of SOPs, corporate policies, forms, surveys and routine communications with documented electronic receipt and tracking to employees,suppliers and contractors. Quizzes and Exams can be created and linked to SOPs and critical documents, so that you can test understanding of the material.
ComplianceWire also enables you to receive “e-acknowledgement” from employees to signify receipt of these critical documents, or an “e-signature” for employees to sign off on their understanding of the information in a validated, Part 11-compliant environment. Leveraging this technology, you gain an auditable record of all activity associated with your critical information.
Manage the Most Complex Training Assignments
ComplianceWire provides the versatility and flexibility to enable you to manage multiple training items within multiple locations and departments. Leveraging the ComplianceWire Platform, you can address these challenges:
- Maintain an unlimited set of training items and curricula with full support for versioning, change control and 21 CFR part 11 requirements.
- Link related training items to meet any knowledge or compliance requirement, and assign these curricula to specific job roles, so when employees transfer to new job roles, they will automatically receive new training.
- Leverage a single device to manage existing learning methods for a blended system that includes instructor-led, classroom, on-the-job and mentoring components.
- Supplement best practice compliance-driven courses with internal content to assure conformance to company-specific procedures.
- Build your own electronic quizzes and exams, and assign these items so they display in the end users’ “To-Do” pages alongside courses, SOPs and other third party materials.
- At a moment’s notice, you are a mouse click away from a complete, chronological history of end user activity, as ComplianceWire maintains full audit trail capability in accordance with 21 CFR Part 11.
- Robust reporting for users, administrators and managers against a wide range of metrics.
Extend Compliance Learning Securely to Non-Employees
If you are responsible not only for the compliance of your own employees, but also physicians, clinicians, suppliers and subcontractors, you can leverage the SaaS model inherent with ComplianceWire. The solution can be ideal, as it maintains your network security (user activity occurs outside your company’s firewall) while also integrating vital nonemployee compliance information for audit-related purposes.
Provide High-Level Executive Dashboards
ComplianceWire provides “compliance status snapshots” so that senior managers can instantly evaluate compliance training effectiveness – and take remedial action if necessary.
Integrate Operator Certification Programs
ComplianceWire enables you to integrate training curricula with established operator certification programs using biometrics and card reader systems, so that machinery will not operate unless the employee has fulfilled training assignments as defined by your organization.