Insights

Complion Article Featured in ACRP’s Flagship Journal, Clinical Researcher

Posted by Abbie Hosta on Apr 5, 2017 10:52:17 AM

Complion is honored to have recently published an article in Clinical Researcher, the peer-reviewed flagship publication of the Association of Clinical Research Professionals (ACRP).

Clinical Researcher is published six times a year and features articles on the latest developments across the spectrum of specialty areas in the clinical research enterprise, as well as highlighting valuable insights and resources from columnists, internal and external news sources, and the Association’s partner organizations.

Written by Complion VP of Professional Services Cristina Ferrazzano Yaussy and Oklahoma Heart Hospital Senior Director James Wetzel, Ensuring Compliance with Part 11: A Site's Perspective focuses on best practices for maintaining maximum efficiency while meeting the challenges of Part 11 compliance.

Drawing on the insight and expertise of these two seasoned professionals, the article explores various aspects of achieving and maintaining Part 11 compliance, including evolving site responsibilities, recommended Standard Operating Procedures (SOPs), required system and software functionality, vendor selection and auditing, and more.

While the debate over government regulation continues to percolate, 21 CFR 11 is an undeniable, inescapable fact of life for clinical researchers, a challenge of imposing proportions, requiring a level of expertise so substantial as to keep many vendors at bay. This article in Clinical Researcher represents industry recognition of Complion’s expertise in the field and willingness to meet those many challenges head-on.

We’re humbled by this recognition, and we hope you’ll take a few minutes to read the article. Click here to access Ensuring Compliance with Part 11: A Site's Perspective.

Ensuring Compliance with Part 11: A Site's Perspective

Topics: News, Compliance, Regulatory Compliance, 21 CFR Part 11