FDA CFR Part11

FDA CFR Part 11 Compliance

21 CRF Part 11 is a section of the Code of Federal Regulation (CFR) which was established by the United States FDA details the criteria for electronic records and signatures. While the 21 CFR relates to Pharmaceuticals and Medical Devices, Part 11 of the regulation is specifically concerned with electronic records and electronic signatures. The regulation permits and authenticates the wide use of electronic technology, compatible with FDA’s requirements to protect public health records. The regulation considers electronic records and signatures to be equivalent to paper records and handwritten signatures. The CFR Part 11 outlines requirement that ensures the authenticity of electronic data and provides guidance to US companies on how they can submit documentation in an electronic form and electronic signatures in alignment with FDA regulation. The CFR Part 11 Compliance encourages organizations to conduct business digitally and ensures the authenticity of electronic data and signatures.

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Our Approach to FDA CFR Part11

Compliance Audit

After a reasonable gestation period, a separate team of experts conducts a Pre-assessment of your setup and ensures all measures are implemented.

Initial study

Conduct an initial study of the business to understand the business processes, the environment and accordingly consolidate the scope.

Certification Support

Our team will provide you complete support and assistance in helping you achieve certification from external auditors.

Scope Definition

Our team spends significant time with your team to determine IT systems and controls that need to be secured and audited.

Continual support

If required we can extend our continual support by offering you Managed Compliance Services to help your organization stay certified.

Gap Analysis

Assess your organization's current compliance status against the CFR Part 11 standard to identify areas that need to be addressed.

Data & Asset Classification

Identify your sensitive data and assets, and classify them to create an asset inventory.

Risk Assessment

Our team conducts a comprehensive Risk Assessment to identify weak areas that could be exploited and lead to an incident of the breach.

Risk Treatment

Our team helps you build strategies and appropriate Risk Treatment measures to help bridge gaps and strengthen security systems. We also assist you in developing and implementing a data breach management response that can blend with your existing Incident Response Plan.

Product/Application Assessment

Our team assesses your product/application against the standard requirements to ensure CFR11 compliance.

User Training

Our team of experts will conduct User Training programs for all personnel covered in scope on their specific CFR 11 Compliance responsibilities. Training materials for future use shall be provided.

Documentation Support

Develop effective documentation for your organization as per the CFR Part 11 requirements.

Policy Rollout Support

We will help you build and rollout effective policies and procedures for your organization, pertaining to CFR Party 11 Compliance.

Why work with VISTA InfoSec?

Vendor Neutral Company - We believe in being your true consulting / audit partner by not indulging in sales of hardware/software that might create bias.

Strictly No Outsourcing - We value your trust in us so we do not outsource your critical assignments to another third party.

Industry Expertise - We will share industry-specific insight and provide relevant recommendations for achieving your goals of compliance.

Years of Experience - Your organization will benefit from our decade-long years of Industry experience and knowledge.

End-to-end support - Our team will hand-hold you at every stage of the assessment and remediation process.

Robust security & risk management solution - We will provide you with a comprehensive solution, designed to meet your requirements.

Reports detailing the analysis finding - We will provide you with documents detailing the findings of the analysis and provide relevant recommendations for the same.

Industry Best Practice - We adopt best practices and advanced tools to ensure that your application is secure against potential attacks and threats.

Frequently Asked Questions on FDA CFR Part11

What is the main purpose of CFR Part 11?

The purpose of establishing CFR Part 11 is to ensure the authenticity of electronic data and signatures and make them equivalent to paper records and handwritten signatures.

Who does 21 CFR Part 11 apply to?

The 21 CFR Part 11 applies to clinical research organizations, pharmaceutical, and medical device companies, who are conducting FDA-regulated research. Any organizations conducting clinical research in the U.S, or submitting their drugs and devices to the FDA for approval, need to comply with CFR Part 11. Every tech or medical device used in clinical research must be compatible with the CFR Part11.

Which records do 21 CFR Part 11 apply to?

The 21 CFR Part 11 applies to any records that are required by the FDA and are being maintained electronically instead of in a physical format. This includes any electronic document records required by the FDA and mentioned in the Predicate Rule.

What does 21 CFR Part 11 require related to electronic signatures?

The FDA considers electronic signatures equivalent to handwritten signatures but requires the electronic signatures to include the printed name of the signer, date and time of the signature executed, unique user ID, digital adopted signature, and meaning of the signature with labeled signing reason.