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CFR Part 11: Definition, Compliance, Tools and Certifications.

21 CFR Part 11, or FDA’s Electronic Records and Signatures rule, is one of the most important regulations for companies in the life sciences industry. The regulation sets specific requirements for companies that use electronic records and signatures in their compliance efforts. This standard is essential for anyone using digital systems to manage data related to FDA-regulated products. In this blog post, we’ll provide an overview of CFR Part 11, including a definition of key terms, compliance tips, and information about available tools and certifications.

First of all let’s understand what is CFR?

The CFR is the Code of Federal Regulations. CFR Part 11 was published in 1997 and became effective in August of that year. CFR Part 11 applies to all electronic records and signatures created, modified, maintained, archived, retrieved, or transmitted under FDA jurisdiction. This includes files such as lab results, audit trails and software source code entries. It defines the criteria by which electronic records and signatures are considered reliable, trustworthy and generally equivalent to paper records.

What is CFR Part 11?
21 CFR Part 11, or FDA’s Electronic Records and Signatures rule, is one of the most important regulations for companies in the life sciences industry. The regulation sets specific requirements for companies that use electronic records and signatures in their compliance efforts. CFR Part 11 is essential for anyone using digital systems to manage data related to FDA-regulated products. In this blog post, we will provide an overview of CFR Part 11, including a definition of key terms, compliance tips, and information about available tools and certifications.

So what does this mean for you and your organization?
If your company uses electronic systems to manage FDA-regulated data, then you are required to comply with CFR Part 11. The Regulation sets out specific requirements for electronic records and signatures, including the use of digital signatures. To comply with the standard, you will need to put in place appropriate controls and procedures, as well as create and maintain accurate records. You will also need to provide training to all employees who use electronic systems in their work.

There are various tools and services that can help you with CFR Part 11 compliance. For example, EASEUS provides software that automates Part 11 compliance tasks such as record keeping and signature verification. The Validation Master Plan offers Part 11 consulting services to help companies assess their compliance risks and put appropriate controls in place.

Compliance with CFR Part 11 is essential for any company that uses electronic systems to manage data regulated by the FDA. By putting the appropriate controls and processes in place, as well as investing in compliance tools and services, you can ensure that your company complies with this important regulation.

Critical elements of CFR Part 11:
There are four main elements of CFR Part 11:

Records must be accurate, complete and tamper-resistant
Record keeping must be reliable and secure
Signed electronic files must be attributed to the signer and linked to the signed file
Electronic signatures must be unique to the person signing the document and be resistant to forgery.
CFR Part 11 Compliance Tools and Services:
Compliance with CFR Part 11 is not optional – it is required for all companies using electronic systems to manage FDA-regulated data. To comply with CFR Part 11, you will need to put in place appropriate controls and procedures, as well as create and maintain accurate records. You will also need to provide training to all employees who use electronic systems in their work. Various CFR Part 11 compliance tools and services are available to assist you with this process.

Certifications available for compliance with CFR Part 11:
There are a number of certifications available for CFR Part 11 compliance. These include the Certified CFR Part 11 Professional (CCP) certification from the Regulatory Affairs Professionals Society (RAPS), as well as the Certified Quality Systems Auditor (CQSA) certification from ASQ .

The best CCP Certification is designed for professionals who work with CFR Part 11 compliance on a daily basis. The certification covers topics such as CFR Part 11 requirements, records and signatures, compliance risks, and mitigation strategies.

The best CQSA Certification is aimed at quality professionals who want to demonstrate their knowledge of quality system auditing. The certification covers topics such as quality principles, audit planning, audit conduct and reporting of results.

Compliance with CFR Part 11 is essential for regulated firms that use electronic records and signatures. There are a number of certifications available that can help you demonstrate your knowledge and understanding of the regulation.

By investing in Part 11 compliance tools and services, as well as pursuing certifications, you can ensure that your company complies with this important regulation.