Security Solutions

Security Solutions

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

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.

Mock Inspection

Mock Inspection

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.

Remediation

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.

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