Prepare for the Electronic Future With Advarra Consulting

Is your organization ready for an audit of your electronic systems? Advarra Consulting provides comprehensive support for compliance with 21 CFR Part 11, HIPAA/HITECH, and EudraLex Annex 11.

Training and Education
Unsure where to start with eTools? Take advantage of our proprietary training curriculum, preparing your organization for the rigors of compliance with US and/or EU regulations.

Assessment
Find any potential gaps in compliance before an inspector does with our rigorous mock inspection. Your organization will receive a detailed report outlining your level of compliance with the regulatory frameworks and recommendations for remediation.

Remediation
What if the assessment reveals gaps? Advarra offers a strategic partner from our consultant network who works to meet your organization’s specific needs. Your Advarra consultant will provide support to fill any compliance gaps, including development of robust processes and staff training.

Learn more about requirements for eTools and compliance. Download our free whitepaper Considerations for Using eTools in Research: Part 11 & System Validation.

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Presented by Advarra

Advarra provides institutional review board (IRB), institutional biosafety committee (IBC) and global research compliance services to clinical trial sponsors, CROs, hospital systems, academic medical centers and investigators. Its robust regulatory expertise and innovative technology ensure the highest standards of research review are met, while putting participants first and meeting complex human research protection oversight requirements.