Achieve Compliance for 21 CFR Part 11 and EU Annex 11 Validation Requirements
ComplianceWire® (formerly Eduneering) is the best-in-class web-based platform designed specifically for highly regulated industries. It is designed to effectively and efficiently automate the creation, delivery, and reporting of your role-based training, qualification and compliance programs. ComplianceWire was built from the ground up to be fully compliant with 21 CFR Part 11 and EU Annex 11 validation requirements. Known as the ‘Gold Standard’ Learning Management System (LMS) for the Life Science industry, this time-tested technology is used extensively by U.S. and global pharmaceutical, medical device and biologics companies as well as global regulatory authorities in the US, China and India.
Since 1999, ComplianceWire®, as well as UL’s Life Science eLearning courses, have been the trusted learning solution used by the FDA to train more than 36,000 global, federal, state and local investigators.
Our comprehensive compliance training solution integrates three critical components:
ComplianceWire® is interoperable with industry-standard systems including HRIS, document management, clinical trials, ERP, MES and other LMSs.
For example, by integrating a document management system with ComplianceWire, an update to a document automatically triggers the creation and/or update of the training item associated with the document, as well as the real time training actions for your learners.
This solves the compliance challenge of how to properly distribute and track training to SOPs and other critical documents – and the changes to those documents – in a compliant, effective and efficient way.
Once alerted, employees can not only read – but also demonstrate learning comprehension through integrated assessments – thereby increasing learning comprehension and compliance.
ComplianceWire® Application Programming Interface (API) provides the building blocks needed to create integrations across systems. Thorough documentation describing how to make use of and integrate via API is available from the link below.
Explore ComplianceWire Developer’s Page →
Explore the additional features that ComplianceWire has to offer.
The same technology platform and coursework used by the FDA’s virtual university is available exclusively to UL customers.
ComplianceWire provides the versatility and flexibility to manage multiple training items within multiple geographic locations and departments.
As a ComplianceWire customer, you’ll have access to our proprietary library of 600+ courses (450 programs developed specifically for Life Sciences organizations) and 100 modules co-developed with the FDA.
We understand where you are, where you’re going and what you want the outcomes to be. Our team brings proven expertise, along with the right mix of capabilities, to deliver the complete learning solution to meet your current needs and to support your organizations’ ongoing journey.
Contact a ComplianceWire product specialist at +1-609-627-5300 or schedule a demo.
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