Security Solutions - Kinetiq
Ensuring Part 11 and HIPAA/HITECH Compliance
With the growing prevalence of technology in research, compliance with 21 CFR Part 11 and HIPAA/HITECH is increasingly critical in research; but many organizations do not have a deep understanding of these regulatory standards.
Kinetiq experts take your organization through a three-step process to build a risk-based program, ensuring you’re compliant now and in the future.
Training and Education
Our proprietary training curriculum prepares your organization for the rigors compliance with Part 11, HIPAA/HITECH, or both. The training covers all aspects of preparation and compliance and delivers sample assessment documents.
Undergo a rigorous mock inspection to reveal any gaps in compliance before an inspector does. You receive a detailed report outlining your level of compliance with the regulatory frameworks and recommendations for remediation.
Kinetiq offers a strategic partner from our independent consultant network who works to meet your organization’s specific needs. Your Kinetiq consultant will provide a road map to filling any compliance gaps, including development of robust processes and staff training.
Where Does Your Organization Stand?
Non-compliance is costly—organizations that are non-compliant risk FDA citation or may even be forced to halt operation
Executive Vice President
A respected expert in the diverse clinical research and regulations compliance field.Schedule a Needs Analysis
“We found the independent mock audit to be of significant value. Not only did it satisfy a specific request from our customers; the excellent team members at Kinetiq were forthcoming with improvement suggestions that went beyond the core audit program.”
Co-founder, CRIO, Inc.