Is Your Tech Platform Ready for CMMC Level 1?

Dec 18, 2024 | Documentation

Author: Jay Martin

In the world of life sciences, cutting-edge technology is essential. But with advanced technology comes the responsibility of protecting sensitive data. If your organization relies on U.S. government funding, achieving Cybersecurity Maturity Model Certification (CMMC) Level 1 compliance is critical. Kalleid can help. As experts in IT policy development for life sciences, Kalleid ensures that organizations are well-prepared to navigate compliance requirements, particularly those companies relying on U.S. government funding and must demonstrate compliance with Cybersecurity Maturity Model Certification (CMMC) Level 1 controls. Kalleid has successfully helped life sciences organizations meet these controls by delivering tailored IT policies that align with industry standards and regulatory requirements.

Why CMMC Level 1 Matters

CMMC Level 1 focuses on safeguarding Federal Contract Information (FCI). This involves implementing 15 basic security controls outlined in the Federal Acquisition Regulation (FAR 52.204-21). These controls, based on the National Institute of Standards and Technology (NIST) framework, are your foundation for robust cybersecurity.

Understanding Level 1 IT Policy

  • Life sciences organizations should identify the subset of controls applicable to basic safeguarding, as defined in the US Government Federal Acquisition Regulation (FAR) 52.204-21. These 15 controls define CMMC Level 1 IT policy for the basic safeguarding of Federal Contract Information (FCI).
  • The National Institute of Standards and Technology (NIST) framework provides the backbone for IT policy compliance. NIST offers practical guidance on following the controls listed in FAR 52.204-21. NIST Security and Privacy Controls for Information Systems and Organizations (Special Publication 800-53) is a comprehensive catalog of controls for federal systems, which includes the FAR controls. NIST SP 800-171 also provides guidance on the FAR controls but is more focused on protecting Controlled Unclassified Information (CUI) on non-federal systems.

Kalleid’s Proven Framework for IT Policy Development

Kalleid offers a systematic and human-centered approach to IT policy implementation that ensures compliance, minimizes organizational disruption, and supports sustainable business growth. Our services include:

1. Identification of CMMC Level 1 Controls

Kalleid works with clients to:

  • Identify the specific IT controls required under FAR 52.204-21.
  • Map these controls to NIST SP 800-53 Rev. 5 standards.
  • Ensure policies reference current and relevant NIST controls.

2. Resource Allocation

Successful IT policy implementation requires careful resource planning. Kalleid helps:

  • Identify project leadership, including a project manager, subject matter experts (SMEs), and the Information Security Officer. Kalleid supplies the technical writer.
  • Develop a realistic project timeline, typically ranging from 6 to 12 months, depending on complexity and resource availability.

3. Policy and Procedure Development

Kalleid employs a proven methodology for building IT policies tailored to the unique needs of life sciences organizations. By leveraging deep expertise in scientific IT solutions, we:

  • Inventory documents: To identify existing IT policies and gaps.
  • Write IT policy documents: To define organizational IT policy that is aligned with CMMC Level 1 controls. Policies outline what to do to meet IT controls.
  • Write procedures: To develop standard operating procedures (SOPs) that strictly correspond to the written IT policies. These SOPs describe how to implement the policies step by step.
  • Collaborate and review documents: To conduct regular writing sessions with SMEs for drafting and revising policies and SOPs. All work undergoes Quality Assurance (QA) reviews to ensure completeness and accuracy.
  • Provide follow-up support: To assist the organization with self-reporting their IT policy via a platform like the Supplier Performance Risk System (SPRS) within the Procurement Integrated Enterprise Environment (PIEE).

Building Resiliency Through IT Policy

Kalleid empowers life sciences organizations by helping them implement NIST-defined controls for meeting CMMC Level 1 IT policy compliance. By reducing cybersecurity risk, Kalleid builds organizational resilience.



Contact us today to learn how we can guide your organization through IT policy compliance through NIST-aligned cybersecurity implementation.

Dana Karen

About the Author

Jay Martin

About Kalleid

Kalleid, Inc. is a boutique IT consulting firm that has served the scientific community since 2014. We work across the value chain in R&D, clinical, and quality areas to deliver support services for software implementations in highly complex, multi-site organizations. At Kalleid, we understand how effective project management plays a key role in ensuring the success of your IT projects. Kalleid project managers have the right mix of technical know-how, domain knowledge and soft skills to effectively manage your project over its full lifecycle. From project planning to go-live, our skilled PMs will identify and apply the most effective methodology (e.g., agile, waterfall, or hybrid) for successful delivery. If you are interested in exploring how Kalleid project managers can benefit your organization, please don’t hesitate to contact us today.