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
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Contact Kinetiq today to schedule a needs analysis.Contact Us