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

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

21 CFR Part 11, or the FDA’s Electronic Records and Signatures rule, is one of the most important regulations for companies in the life sciences industry. The regulation sets forth 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 products regulated by the FDA. In this blog post, we will provide an overview of CFR Part 11, including a definition of key terms, compliance tips, and information on available tools and certifications.

First of all, let us understand what CFR is?

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 records such as laboratory results, audit trails, and software source code listings. It establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and generally equivalent to paper records.

What is CFR Part 11?

21 CFR Part 11, or the FDA’s Electronic Records and Signatures rule, is one of the most important regulations for companies in the life sciences industry. The regulation sets forth 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 products regulated by the FDA. In this blog post, we will provide an overview of CFR Part 11, including a definition of key terms, compliance tips, and information on 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 forth specific requirements for electronic records and signatures, including the use of digital signatures. In order 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 for all employees who use electronic systems in their work.

There are a number of 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. Validation Master Plan offers Part 11 consulting services to help companies assess their compliance risks and put in place appropriate controls.

CFR Part 11 compliance is essential for any company using electronic systems to manage FDA-regulated data. By putting in place the right controls and procedures, as well as investing in compliance tools and services, you can ensure that your company is compliant with this important regulation.

Critical Components of CFR Part 11:

There are four key components of CFR Part 11:

  • Records must be accurate, complete, and tamper-resistant
  • Recordkeeping must be reliable and secure
  • Signed electronic records must be attributable to the signatory and linked to the signed record
  • Electronic signatures must be unique to the individual signing the document and resistant to forgery.

CFR Part 11 Compliance Tools and Services:

CFR Part 11 compliance is not optional – it is required for all companies that use electronic systems to manage FDA-regulated data. In order 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 for all employees who use electronic systems in their work. There are a number of CFR Part 11 compliance tools and services available to help you with this process.

Certifications Available for CFR Part 11 Compliance:

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 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 CQSA certification is for quality professionals who want to demonstrate their knowledge of quality systems auditing. The certification covers topics such as quality principles, audit planning, conducting an audit, and reporting results.

CFR Part 11 compliance is essential for regulated companies using 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 is compliant with this important regulation.

Prerequisites for CFR Part 11:

There are 7 critical requirements for CFR Part 11 compliance.

1. Data integrity

The EPA’s Part 11 rules state that you must have a digital process and controls in place to guarantee the “authenticity, integrity, and, when appropriate, confidentiality of electronic records.”

The main goal of Part 11 is to make sure the data and information you gather while developing your product are accurate, traceable, suitable for your purpose, and secure from loss or misuse. The risk of product failure will be reduced by imposing all of Part 11’s safeguards. It’s a smart investment.

2. Data retrieval

The regulations state that you should have the tools to preserve your documentation “to enable their timely and accurate retrieval throughout the records retention period.” Controlling the development process so that your records are automatically archived, indexed, and accessible on-demand will assist you in:

  • Examining and checking for non-compliance and problems, audit your own system thoroughly.
  • Tracking and tracing ‘the root causes’ of any identified non-conformities in your system
  • Supporting external audits – respond quickly to regulatory questions to keep your business compliant

3. Validation

You must formally describe how your system is supposed to function, then write scripts and testing procedures to ensure it functions as intended. However, it may seem like a lot of work, validating your QMS will show that it is fit for purpose and give you and the regulator assurance that you are capable of delivering goods according to the required standards.

4. Audit Trails

Part 11 requires you to have a complete version history available for every quality document in your system, via secured, computer-generated, and time-stamped audit trails in order to independently record the date and time of operation entries and actions that create, modify, or delete electronic records.

The more details you can get on every change and sign-off event, the better. By recording the author, date, and time of each modification and sign-off event, you’ll have full traceability and accountability for all decision-making activities throughout the development process. It will save time and resources than using a paper-based system in auditing and investigating procedures.

5. Operational Controls

The usage of operational system checks so as for the enforcement of appropriate sequential steps and events is another important requirement of Part 11.

The ability to create automated workflows for obtaining approvals and signatures will give you more control over your team and procedure as you manage the implementation process. They can ensure important papers are collected together before being examined by various people at specific times in your plan. Part 11 aids in the creation of order and clarity in potentially complicated procedures, lowering the danger of a company making costly errors.

6. Security Controls

Part 11 sets out the controls you’ll have over who has access and how it’s changed within your system. The rules include several precise criteria to prevent data loss and deletion by accident, as well as security breaches that can cause customer damage, business failure, and government fines.

7. Electronic signatures

Part 11 mentions the mandatory usage of e-signatures.

Part 11 requires that electronic signatures be digitally signed documents with a printed name of the signer, the date/time the signature was applied, and the ‘meaning’ or purpose of the electronic signature as part of an evolving and uneditable audit trail. However, this is not where things end.

In an effort to match the level of legal confidence provided by a ‘wet signature,’ Part 11 has made digital approval authentication procedures far more demanding. To guarantee identity verification and protection from fraud, you’ll need tight controls over digital documents and processes. It would be significantly simpler to fabricate a pen and ink signature on a test result than it is to falsify an electronic signature under FDA rules right now.

CFR Part 11 Compliance Software:

EASEUS CFR Part 11 compliance software is a web-based application that automates CFR Part 11 compliance tasks, such as record keeping and signature verification. The software includes a range of features, such as an audit trail, electronic signatures, and security controls. EASEUS Part 11 compliance software is available in both on-premise and cloud-based versions.

Visure Requirements ALM Platform:

Visure is one of the most trusted modern ALM platforms that specialize in requirements management for organizations of all sizes across the globe. It’s a must-have tool for teams building complex products, systems, and software, which require end-to-end traceability from conception to testing and deployment, all the way to source code, along with standard certification compliance.

The CFR Part 11 Module in Visure Requirements ALM Platform is a complete solution for companies who need to comply with CFR Part 11. The module includes a CFR Part 11 checklist, which helps you to assess your company’s compliance status, and a CFR Part 11 template, which can be used to create CFR Part 11 compliant quality documents.

Conclusion:

CFR Part 11 is a set of regulations from the United States Food and Drug Administration (FDA) that apply to electronic records and signatures in the life sciences industry. The key components of CFR Part 11 are authentication, integrity, security, and retention. To comply with the standard, companies must have a system for tracking changes to electronic records, authenticating user actions, and maintaining audit trails. Visure Requirements ALM Platform helps companies meet these requirements by providing a secure platform for managing requirements and change management processes. Request a free 30-day trial at Visure Requirements ALM Platform today to see how our software can help you achieve compliance with CFR Part 11.

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