Compliances

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CMMC Services

CMMC, or Cybersecurity Maturity Model Certification, is a certification program developed by the U.S. Department of Defense (DoD) for the Defense Industrial Base (DIB) contractors. It serves as a unifying standard to ensure that DoD contractors adequately protect sensitive information. The CMMC framework assesses and enhances the cybersecurity posture of DIB contractors, requiring them to meet certain security requirements and undergo formal third-party audits. The program is designed to enforce the protection of sensitive unclassified information shared by the Department with its contractors and subcontractors¹².

  • The CMMC model categorizes cybersecurity best practices at various maturity levels, ranging from basic cyber hygiene to advanced. For instance, it includes practices from NIST SP 800-171 Rev 2 for protecting Controlled Unclassified Information (CUI) in nonfederal systems and organizations. The certification is evolving, with CMMC 2.0 simplifying the original five levels down to three, aligning with established NIST cybersecurity standards². Compliance with CMMC will become a prerequisite for DoD contract awards once the framework is fully implemented¹².

    • HIPPA Compliance

    HIPAA compliance ensures that Protected Health Information (PHI) is properly safeguarded, setting boundaries on the use and disclosure of medical information by covered entities and their business associates.

  • HIPAA services typically involve helping organizations become compliant with these regulations, which includes implementing necessary safeguards, policies, and procedures to protect PHI, training staff, and conducting risk assessments. Compliance is crucial for healthcare providers, insurance companies, and other entities that handle sensitive health information to avoid penalties and ensure patient trust and safety.
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    NIST Compliance

    NIST, the National Institute of Standards and Technology, provides a variety of services aimed at promoting innovation and industrial competitiveness by advancing measurement science, standards, and technology. Some of the key services offered by NIST include:

    • Information Technology Security Services: Guidance on securing IT systems, including best practices and tools for managing IT security services throughout their lifecycle¹.
    • Cybersecurity Framework: A comprehensive set of guidelines and best practices for private sector organizations to improve their cybersecurity risk management. The framework is flexible and can be integrated with existing security processes².
    • Weights and Measures Services: Ensuring the fairness and efficiency of sales through services that underpin the efficiency of a significant portion of the U.S. economy³.
    • These services are crucial for maintaining standards that support the economy and protect sensitive information across various industries.

    21 CFR Part 11

    21 CFR Part 11 is a regulation under Title 21 of the Code of Federal Regulations that pertains to the United States Food and Drug Administration (FDA). It sets the criteria for the acceptance of electronic records and electronic signatures as equivalent to paper records and handwritten signatures. This regulation is crucial for companies in the pharmaceutical, medical device, biotech, and other FDA-regulated industries, as it outlines the requirements for maintaining electronic documentation and using electronic signatures in a manner that is trustworthy and reliable12.

  • The regulation requires the implementation of controls such as audits, system validations, audit trails, and documentation for software and systems involved in processing electronic data. These measures ensure the integrity of electronic records and the authenticity of electronic signatures, thereby facilitating the transition from paper-based to electronic documentation systems23. Compliance with 21 CFR Part 11 is essential for organizations to meet FDA requirements for electronic records1.
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