FDA CFR Part11 – Cyber Matterz

Cyber Matterz

FDA CFR Part 11 Compliance

21 CFR Part 11 is a segment of the Code of Federal Regulations (CFR) established by the U.S. FDA, delineating criteria for electronic records and signatures. While 21 CFR pertains to Pharmaceuticals and Medical Devices, Part 11 specifically addresses electronic records and signatures. This regulation authorizes and verifies the extensive use of electronic technology, aligning with FDA requirements to safeguard public health records. It deems electronic records and signatures as equivalent to their paper and handwritten counterparts. CFR Part 11 outlines requirements ensuring the authenticity of electronic data and guides U.S. companies on submitting documentation and electronic signatures in compliance with FDA regulations. CFR Part 11 Compliance promotes digital business transactions, assuring the genuineness of electronic data and signatures.

Cyber Matterz ApproachTo FDA CFR Part11

Initial study

Begin with an initial business analysis to grasp the intricacies of your card processes and the surrounding environment. Afterward, streamline the scope.

Scope Definition

Gain insight into your company's functions, controls, and systems to delineate the necessary scope (People, Process, and Technology).

Gap Analysis

Evaluate your organization against the CFR Part 11 standard to pinpoint areas that demand focus.

Awareness Training

Provide a concise CFR Part 11 Awareness Training session for your organization.

Product/Application Assessment

The Cyber Matterz Team evaluates your product or application to verify compliance with CFR11 standard requirements.

Risk Assessment

Undertake a comprehensive risk assessment to uncover vulnerabilities and deficiencies that may pose a threat to your organization's business-critical assets.

Risk Treatment

Our specialists will prioritize the identified risks and support you in devising suitable measures for risk treatment.

Documentation Support

We aid in developing policy and procedure documents, incorporating input and validation from your team.

Policy rollout support

Our process and technical team will work closely with your team to support the implementation of CFR Part 11 and associated policy rollouts.

Rollout User Training

Implement a user training initiative on specific CFR Part 11 responsibilities for all personnel within the defined scope, accompanied by provided training materials.

Pre-Assessment

An independent team of specialists performs a preliminary evaluation of your setup and assesses the implemented measures after a reasonable incubation period.

Attestation

We aid you in achieving certification through a certification body of your choosing once all controls are verified to be in position.

Continual Support

If required, we offer continuous support through Managed Compliance Services to help your organization maintain its certified status.

Why

Cyber Matterz?

We strive to be your genuine consulting and audit partner, refraining from the sale of hardware/software to prevent bias.
Your trust is paramount, and we do not delegate your critical assignments to third parties.
Benefit from our industry-specific insights, receiving relevant recommendations to achieve your compliance goals.
Your organization will leverage our extensive decade-long industry experience and knowledge.
The Cyber Matterz Team will guide you at every stage of the assessment and remediation process, offering end-to-end support.
Receive a comprehensive solution tailored to meet your specific requirements.
Access documents detailing the findings of the analysis along with relevant recommendations.
We adhere to industry best practices and utilize advanced tools to ensure the security of your application against potential attacks and threats.

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December 2024

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