---
title: 9+ FAQs on FDA 21 CFR Part 11 Compliance | Document Control
description: To help companies navigate the regulation process, we’ve compiled a guide on the 9 most common questions companies need answers to. Learn here.
image: https://info.docxellent.com/hubfs/Top%20FAQs%20on%20FDA%2021%20CFR%20Part%2011%20Compliance.jpg
---

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      #### [ENSUR](https://docxellent.com/products/ensur-document-management-system/)
      
       ENSUR is an easy-to-use, configurable, web-based Document Management and quality Control Software System that will dramatically help you to improve and manage the efficiency of paper based or uncontrolled electronic file based processes.
    - [ENSUR Lite](https://info.docxellent.com/ensur-lite)
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      #### [Document Management 101](https://docxellent.com/guide-to-document-management-101/)
      
      Cut the Clutter, Boost Efficiency: Dive into our Document Management 101 guide and discover how taking your files digital unlocks hidden productivity, strengthens compliance, and unleashes the full potential of your workflows.
    - [ENSUR Cloud](https://docxellent.com/products/ensurcloud/)
      
      [![ENSUR Cloud Document Management System](https://docxellent.com/wp-content/uploads/2017/09/ENSUR-Cloud-350x210.jpg)](https://docxellent.com/products/ensurcloud/)
      
      #### [ENSUR Cloud](https://docxellent.com/products/ensurcloud/)
      
       Whether you’re an existing customer, a company looking to make a change in your provider or implementing your first document control, packaging specification, training management or quality system, DocXellent can provide the option of on-premises or a robust, secure and proven cloud based installation.
    - [ENSUR Case Studies](https://docxellent.com/products/case-studies/)
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      #### [CAPA Solutions](https://docxellent.com/document-control-solutions/capa-solutions/)
      
       Easily collect, correlate, investigate and make informed improvements to your processes with our CAPA management software, ENSUR.
    - [Change Control](https://docxellent.com/document-control-solutions/change-control/)
      
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      #### [Change Control](https://docxellent.com/document-control-solutions/change-control/)
      
       See how our document control management software, ENSUR, can automate your change control processes.
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      #### [Document Control Software](https://docxellent.com/document-control-solutions/document-control-software/)
      
       Control your organization’s content across the globe or down the hallway with our flexible, secure, user-friendly online document control software, ENSUR.
    - [Version Control](https://docxellent.com/document-control-solutions/version-control/)
      
      [![Version Document Control](https://docxellent.com/wp-content/uploads/2017/11/Version-Control--350x210.jpg)](https://docxellent.com/document-control-solutions/version-control/)
      
      #### [Version Control](https://docxellent.com/document-control-solutions/version-control/)
      
       Your document control management protocol encompasses a wide variety of processes integral to the continued flow of your business. Version control, and how it’s handled, is often a pain point for companies, especially those managing content with paper or a file share.
    - [Intellectual Property Management](https://docxellent.com/document-control-solutions/intellectual-property-control/)
      
      [![Intellectual Property Management Deviations & Complaints](https://docxellent.com/wp-content/uploads/2017/09/Intellectual-Property-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/intellectual-property-control/)
      
      #### [Intellectual Property Management](https://docxellent.com/document-control-solutions/intellectual-property-control/)
      
       Our document management system, ENSUR, helps you manage your critical business documents with a configurable level of security and control.
    - [Packaging Management System](https://docxellent.com/document-control-solutions/packaging-management/)
      
      [![Packaging Management Specification Data](https://docxellent.com/wp-content/uploads/2017/09/Packaging-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/packaging-management/)
      
      #### [Packaging Management System](https://docxellent.com/document-control-solutions/packaging-management/)
      
       See how you can easily manage packaging documents, specifications and suppliers with our comprehensive document control software, ENSUR.
    - [Quality Control Management](https://docxellent.com/document-control-solutions/quality-management/)
      
      [![Quality Control Document Management](https://docxellent.com/wp-content/uploads/2014/05/Quality-Control-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/quality-management/)
      
      #### [Quality Control Management](https://docxellent.com/document-control-solutions/quality-management/)
      
       Guaranteeing that your products and services meet the standards of your clients is easy with our document management and quality control software, ENSUR.
    - [Specification Document Management](https://docxellent.com/document-control-solutions/specification-management/)
      
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      #### [Specification Document Management](https://docxellent.com/document-control-solutions/specification-management/)
      
       Specification Management is easy with our document management software, ENSUR. We can even migrate legacy content seamlessly for easy access.
    - [Training Management](https://docxellent.com/document-control-solutions/training-management/)
      
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      #### [Training Management](https://docxellent.com/document-control-solutions/training-management/)
      
       We can help exceed your quality document management goals and report on employee training in seconds with our document management software, ENSUR.
    - [Document Migration](https://docxellent.com/document-control-solutions/document-management-software-migration/)
      
      [![Document Management Software Migration](https://docxellent.com/wp-content/uploads/2019/01/docxellent_docmigration.jpg)](https://docxellent.com/document-control-solutions/document-management-software-migration/)
      
      #### [Document Migration](https://docxellent.com/document-control-solutions/document-management-software-migration/)
      
       DocXellent has helped many clients, from Fortune 500 companies to smaller firms, migrate data into our  ENSUR document control system.
- [Industries](https://docxellent.com/industries/) 
    - [Biotech](https://docxellent.com/industries/biotech-document-management/)
      
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      #### [Biotech](https://docxellent.com/industries/biotech-document-management/)
      
      Biotech chaos got you down? DocXellent's ENSUR streamlines workflows, conquers compliance, and accelerates breakthroughs. Be the first to market, not the first to rework.
    - [Food and Beverage](https://docxellent.com/industries/food-beverage-quality-management-software/)
      
      [![Document Control Software for the Food and Beverage Industry](https://docxellent.com/wp-content/uploads/2017/09/Food-and-Beverage-350x210.jpg.webp)![Document Control Software for the Food and Beverage Industry](https://docxellent.com/wp-content/uploads/2017/09/Food-and-Beverage-350x210.jpg.webp)](https://docxellent.com/industries/food-beverage-quality-management-software/)
      
      #### [Food and Beverage](https://docxellent.com/industries/food-beverage-quality-management-software/)
      
      Our document management software helps companies in the food & beverage industry comply with FDA audit & SQF audit control guidelines. Contact DocXellent today!
    - [Laboratories](https://docxellent.com/industries/laboratories/)
      
      [![Quality Management Software Labs](https://docxellent.com/wp-content/uploads/2017/09/Quality-Control-Software-Labs-350x210.jpg.webp)![Quality Management Software Labs](https://docxellent.com/wp-content/uploads/2017/09/Quality-Control-Software-Labs-350x210.jpg.webp)](https://docxellent.com/industries/laboratories/)
      
      #### [Laboratories](https://docxellent.com/industries/laboratories/)
      
      Laboratory companies must control their business content in accordance with the Clinical Laboratory Improvement Amendments (CLIA). See how our document control software can help.
    - [Medical Devices](https://docxellent.com/industries/medical-device-document-control/)
      
      [![Medical Device Document Control](https://docxellent.com/wp-content/uploads/2017/09/Medical-Devices-350x210.jpg.webp)![Medical Device Document Control](https://docxellent.com/wp-content/uploads/2017/09/Medical-Devices-350x210.jpg.webp)](https://docxellent.com/industries/medical-device-document-control/)
      
      #### [Medical Devices](https://docxellent.com/industries/medical-device-document-control/)
      
      Our document management software can help with your medical device compliance. Contact us today for more document control information on the medical device industry.
    - [Pharmaceuticals](https://docxellent.com/industries/pharma/)
      
      [![Pharmaceutical Document Control Software Application](https://docxellent.com/wp-content/uploads/2014/04/medicine-350x210.jpg.webp)![Pharmaceutical Document Control Software Application](https://docxellent.com/wp-content/uploads/2014/04/medicine-350x210.jpg.webp)](https://docxellent.com/industries/pharma/)
      
      #### [Pharmaceuticals](https://docxellent.com/industries/pharma/)
      
      Our document control software helps you easily satisfy auditor requests with a document master list for FDA & EPA compliance. Quality Document Control.
    - [Other](https://docxellent.com/industries/other/)
      
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      #### [Other](https://docxellent.com/industries/other/)
      
      Unlock seamless document control in any industry with ENSUR. Whether you're looking to navigate regulatory requirements, ensure quality standards, or optimize your workflows, our powerful document management software is tailored to meet your specific needs. Learn more about the specific industries we cater to here.
- [Services and Support](https://docxellent.com/service-support/) 
    - [ENSUR Support](https://docxellent.com/service-support/document-control-software-support/)
      
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      #### [ENSUR Support](https://docxellent.com/service-support/document-control-software-support/)
      
       The DocXellent support team is available twenty-four hours a day; seven days a week; three hundred sixty-five days a year. Our U.S. based team works around the clock to keep your business running.
    - [Resources and Information](https://docxellent.com/resources/)
      
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      #### [Resources and Information](https://docxellent.com/resources/)
      
       Need to access your industry standards and regulations? Visit our DocXellent resources page for more useful information on document control systems and regulations.
- [Our Company](https://docxellent.com/company/) 
    - [About Us](https://docxellent.com/company/about-us/)
      
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      #### [About Us](https://docxellent.com/company/about-us/)
      
       DocXellent has been providing a trusted, web based document management system with quality control management solutions to companies from start-up businesses to the Fortune 500 since 1983.
    - [Meet the Team](https://docxellent.com/team/)
      
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      #### [Meet the Team](https://docxellent.com/team/)
      
       Meet some of the team that makes DocXellent tick. Get to know the people who will be partnering with you in your success!
    - [Customers and Partners](https://docxellent.com/company/customers-partners/)
      
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      #### [Customers and Partners](https://docxellent.com/company/customers-partners/)
      
       These are the brands and organizations that have experienced the power of our document control system, ENSUR
    - [Blog](https://info.docxellent.com/blog)
      
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      #### [Blog and Announcements](https://info.docxellent.com/blog)
      
       Stay up to date on product and industry updates and get an inside look at our company.
- [Contact](https://docxellent.com/company/contact-us/) 
    - [Contact Us](https://docxellent.com/company/contact-us/)
      
      #### [Contact Us](https://docxellent.com/company/contact-us/)
      
       Contact Us to receive more information about our product and services including document management software.
    - [Document Control Sales](https://docxellent.com/company/contact-us/sales/)
      
      #### [Document Control Sales](https://docxellent.com/company/contact-us/sales/)
      
       We are happy to answer any questions you have about our ENSUR software and we will gladly go at your pace.
    - [Contact Support](https://docxellent.com/company/contact-us/support/)
      
      #### [Contact Support](https://docxellent.com/company/contact-us/support/)
      
       We are here to help. Connect with one of our experienced support team members who can get you an answer to any question you may have.
    - [Request a Demo](https://docxellent.com/request-demo/)
      
      #### [Request a Demo](https://docxellent.com/request-demo/)
      
       Get in touch to request a demo of our ENSUR document control management software.
- [Request Demo](https://docxellent.com/request-demo/)

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            [![ENSUR Document Management System](https://docxellent.com/wp-content/uploads/2017/09/ENSUR-350x210.jpg)](https://docxellent.com/products/ensur-document-management-system/)
            
            #### [ENSUR](https://docxellent.com/products/ensur-document-management-system/)
            
             ENSUR is an easy-to-use, configurable, web-based Document Management and Quality Control Software System that will dramatically help you to improve and manage the efficiency of paper based or uncontrolled electronic file based processes.
          - [ENSUR Lite](https://info.docxellent.com/ensur-lite)
          - [Document Management 101](https://docxellent.com/guide-to-document-management-101/)
            
            [![](https://docxellent.com/wp-content/uploads/2024/01/Document-Management-101-Navigation-Image.jpg)](https://docxellent.com/guide-to-document-management-101/)
            
            #### [Document Management 101](https://docxellent.com/guide-to-document-management-101/)
            
            Cut the Clutter, Boost Efficiency: Dive into our Document Management 101 guide and discover how taking your files digital unlocks hidden productivity, strengthens compliance, and unleashes the full potential of your workflows.
          - [ENSUR Cloud](https://docxellent.com/products/ensurcloud/)
            
            [![ENSUR Cloud Document Management System](https://docxellent.com/wp-content/uploads/2017/09/ENSUR-Cloud-350x210.jpg)](https://docxellent.com/products/ensurcloud/)
            
            #### [ENSUR Cloud](https://docxellent.com/products/ensurcloud/)
            
             Whether you’re an existing customer, a company looking to make a change in your provider or implementing your first document control, packaging specification, training management or quality system, DocXellent can provide the option of on-premises or a robust, secure and proven cloud based installation.
          - [ENSUR Case Studies](https://docxellent.com/products/case-studies/)
    - [Solutions](https://docxellent.com/document-control-solutions/) 
          - [CAPA Solutions](https://docxellent.com/document-control-solutions/capa-solutions/)
            
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            #### [CAPA Solutions](https://docxellent.com/document-control-solutions/capa-solutions/)
            
             Easily collect, correlate, investigate and make informed improvements to your processes with our CAPA management software, ENSUR.
          - [Change Control](https://docxellent.com/document-control-solutions/change-control/)
            
            [![Change Control Document Management Solution](https://docxellent.com/wp-content/uploads/2017/09/Change-Control-350x210.jpg)](https://docxellent.com/document-control-solutions/change-control/)
            
            #### [Change Control](https://docxellent.com/document-control-solutions/change-control/)
            
             See how our document control management software, ENSUR, can automate your change control processes.
          - [Document Control Software](https://docxellent.com/document-control-solutions/document-control-software/)
            
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            #### [Document Control Software](https://docxellent.com/document-control-solutions/document-control-software/)
            
             Control your organization’s content across the globe or down the hallway with our flexible, secure, user-friendly online document control software, ENSUR.
          - [Version Control](https://docxellent.com/document-control-solutions/version-control/)
            
            [![Version Document Control](https://docxellent.com/wp-content/uploads/2017/11/Version-Control--350x210.jpg)](https://docxellent.com/document-control-solutions/version-control/)
            
            #### [Version Control](https://docxellent.com/document-control-solutions/version-control/)
            
             Your document control management protocol encompasses a wide variety of processes integral to the continued flow of your business. Version control, and how it’s handled, is often a pain point for companies, especially those managing content with paper or a file share.
          - [Intellectual Property Management](https://docxellent.com/document-control-solutions/intellectual-property-control/)
            
            [![Intellectual Property Management Deviations & Complaints](https://docxellent.com/wp-content/uploads/2017/09/Intellectual-Property-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/intellectual-property-control/)
            
            #### [Intellectual Property Management](https://docxellent.com/document-control-solutions/intellectual-property-control/)
            
             Our document management system, ENSUR, helps you manage your critical business documents with a configurable level of security and control.
          - [Packaging Management System](https://docxellent.com/document-control-solutions/packaging-management/)
            
            [![Packaging Management Specification Data](https://docxellent.com/wp-content/uploads/2017/09/Packaging-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/packaging-management/)
            
            #### [Packaging Management System](https://docxellent.com/document-control-solutions/packaging-management/)
            
             See how you can easily manage packaging documents, specifications and suppliers with our comprehensive document control software, ENSUR.
          - [Quality Control Management](https://docxellent.com/document-control-solutions/quality-management/)
            
            [![Quality Control Document Management](https://docxellent.com/wp-content/uploads/2014/05/Quality-Control-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/quality-management/)
            
            #### [Quality Control Management](https://docxellent.com/document-control-solutions/quality-management/)
            
             Guaranteeing that your products and services meet the standards of your clients is easy with our document management and quality control software, ENSUR.
          - [Specification Document Management](https://docxellent.com/document-control-solutions/specification-management/)
            
            [![ENSUR Specification Management System](https://docxellent.com/wp-content/uploads/2017/09/Specification-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/specification-management/)
            
            #### [Specification Document Management](https://docxellent.com/document-control-solutions/specification-management/)
            
             Specification Management is easy with our document management software, ENSUR. We can even migrate legacy content seamlessly for easy access.
          - [Training Management](https://docxellent.com/document-control-solutions/training-management/)
            
            [![Web-Based Training Management Software](https://docxellent.com/wp-content/uploads/2017/09/Training-Management-350x210.jpg)](https://docxellent.com/document-control-solutions/training-management/)
            
            #### [Training Management](https://docxellent.com/document-control-solutions/training-management/)
            
             We can help exceed your quality document management goals and report on employee training in seconds with our document management software, ENSUR.
          - [Document Migration](https://docxellent.com/document-control-solutions/document-management-software-migration/)
    - [Industries](https://docxellent.com/industries/) 
          - [Biotech](https://docxellent.com/industries/biotech-document-management/)
            
            [![](https://docxellent.com/wp-content/uploads/2024/01/Biotech-Menu-Image.jpg)![](https://docxellent.com/wp-content/uploads/2024/01/Biotech-Menu-Image.jpg)](https://docxellent.com/industries/biotech-document-management/)
            
            #### [Biotech](https://docxellent.com/industries/biotech-document-management/)
            
            Biotech chaos got you down? DocXellent's ENSUR streamlines workflows, conquers compliance, and accelerates breakthroughs. Be the first to market, not the first to rework.
          - [Food and Beverage](https://docxellent.com/industries/food-beverage-quality-management-software/)
            
            [![Document Control Software for the Food and Beverage Industry](https://docxellent.com/wp-content/uploads/2017/09/Food-and-Beverage-350x210.jpg.webp)![Document Control Software for the Food and Beverage Industry](https://docxellent.com/wp-content/uploads/2017/09/Food-and-Beverage-350x210.jpg.webp)](https://docxellent.com/industries/food-beverage-quality-management-software/)
            
            #### [Food and Beverage](https://docxellent.com/industries/food-beverage-quality-management-software/)
            
            Our document management software helps companies in the food & beverage industry comply with FDA audit & SQF audit control guidelines. Contact DocXellent today!
          - [Laboratories](https://docxellent.com/industries/laboratories/)
            
            [![Quality Management Software Labs](https://docxellent.com/wp-content/uploads/2017/09/Quality-Control-Software-Labs-350x210.jpg.webp)![Quality Management Software Labs](https://docxellent.com/wp-content/uploads/2017/09/Quality-Control-Software-Labs-350x210.jpg.webp)](https://docxellent.com/industries/laboratories/)
            
            #### [Laboratories](https://docxellent.com/industries/laboratories/)
            
            Laboratory companies must control their business content in accordance with the Clinical Laboratory Improvement Amendments (CLIA). See how our document control software can help.
          - [Medical Devices](https://docxellent.com/industries/medical-device-document-control/)
            
            [![Medical Device Document Control](https://docxellent.com/wp-content/uploads/2017/09/Medical-Devices-350x210.jpg.webp)![Medical Device Document Control](https://docxellent.com/wp-content/uploads/2017/09/Medical-Devices-350x210.jpg.webp)](https://docxellent.com/industries/medical-device-document-control/)
            
            #### [Medical Devices](https://docxellent.com/industries/medical-device-document-control/)
            
            Our document management software can help with your medical device compliance. Contact us today for more document control information on the medical device industry.
          - [Pharmaceuticals](https://docxellent.com/industries/pharma/)
            
            [![Pharmaceutical Document Control Software Application](https://docxellent.com/wp-content/uploads/2014/04/medicine-350x210.jpg.webp)![Pharmaceutical Document Control Software Application](https://docxellent.com/wp-content/uploads/2014/04/medicine-350x210.jpg.webp)](https://docxellent.com/industries/pharma/)
            
            #### [Pharmaceuticals](https://docxellent.com/industries/pharma/)
            
            Our document control software helps you easily satisfy auditor requests with a document master list for FDA & EPA compliance. Quality Document Control.
          - [Other](https://docxellent.com/industries/other/)
            
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            #### [Other](https://docxellent.com/industries/other/)
            
            Unlock seamless document control in any industry with ENSUR. Whether you're looking to navigate regulatory requirements, ensure quality standards, or optimize your workflows, our powerful document management software is tailored to meet your specific needs. Learn more about the specific industries we cater to here.
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             Need to access your industry standards and regulations? Visit our DocXellent resources page for more useful information on document control systems and regulations.
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             Meet some of the team that makes DocXellent tick. Get to know the people who will be partnering with you in your success!
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# Top FAQs on FDA 21 CFR Part 11 Compliance

September 06, 2022

![Top FAQs on FDA 21 CFR Part 11 Compliance](https://info.docxellent.com/hs-fs/hubfs/Top%20FAQs%20on%20FDA%2021%20CFR%20Part%2011%20Compliance.jpg?width=2430&name=Top%20FAQs%20on%20FDA%2021%20CFR%20Part%2011%20Compliance.jpg)

As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those risks. However, exactly what this standard entails and what the FDA expects can be confusing. To help companies navigate this regulation process, we’ve compiled a guide on the nine most common questions companies have when it comes to 21 CFR Part 11 compliance. Read on to learn more.

### **FDA 21 CFR Part 11 FAQs**

**1. What is FDA 21 CFR Part 11?**

[The FDA](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application) defines 21 CFR Part 11 as the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Specifically, it’s guidance on how United States-based companies can submit documentation in an electronic form and the criteria for approved electronic signatures. The acronym CFR stands for “Code of Federal Regulations,” and Part 11 refers specifically to electronic signatures that are submitted to the FDA.

Generally, if your organization follows all the encompassed Part 11 requirements and can prove the validity of electronic signatures to an auditor, the FDA will accept those electronic signatures in place of traditional paper-based ones.

The FDA issued a guidance paper that provides further clarification on electronic records and electronic signatures: [Part 11, Electronic Records; Electronic Signatures — Scope and Application](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application)

**2. What are the main purposes of FDA 21 CFR Part 11?**

When the world began turning paper processes digital, the government needed a way to regulate electronic documents and preserve data authenticity. With the help of CFR Part 11, the FDA works to ensure that all digital records are properly kept and risk-free. Specifically, this regulation helps companies learn how to:

- - Store data safely and securely
    - Track data changes
    - Guarantee data is not corrupted or lost
    - Ensure that electronic signatures cannot be disputed
    - Prevent and identify falsified records

**3. Who does this regulation apply to?**

Generally, Part 11 applies to drug makers, [medical device manufacturers](https://docxellent.com/industries/medical-device-document-control/), [biotech companies](https://docxellent.com/industries/life-sciences-document-control-software/), biologics developers, contract research organizations (CROs), and other FDA-regulated industries, with some specific exceptions. If you are part of any of these industries, this regulation applies to your company.

**4. What happens if I don’t comply?**

In highly regulated industries like the ones Part 11 applies to, governing bodies are always watching. So, if your company doesn’t meet agreed-upon standards, you won’t fly under the radar for long. If the FDA finds elements of your processes that don’t measure up, they will first issue a Form 483. This is essentially a warning, saying you need to correct certain areas. For the past several years, the FDA has issued around five thousand of these forms annually.

After this form is administered, the FDA considers your company’s case and then determines what further action, if any, is appropriate to protect public health. This means that if you don’t reach compliance your company could be facing a hefty fine – or worse. Long story short, meeting CFR Part 11 compliance is important and necessary for companies using digital documentation.

**5. What are FDA electronic signatures?**

An electronic signature, or an e-signature, is an electronic symbol, usually the person's name, that is attached to a form or contract and demonstrates consent. They are legally binding for all transactions they are used in. More simply put, an e-signature is just a signature that’s been attained digitally. According to the FDA, basic requirements for electronic signatures are as follows:

- - Each electronic signature must be unique to the individual and should not be reused or reassigned
    - The identity of the individual must be verified before establishing or sanctioning the individual’s electronic signature
    - Electronic signatures that are not based upon biometrics must employ at least two distinct identification components such as an identification code and password
    - No two individuals can have the same identification code and password combination
    - Identification code and password issuances must be periodically checked, recalled, or revised (e.g., to cover such events as password aging)
    - The system must use transaction safeguards to prevent unauthorized use of passwords and/or identification codes and to detect and report any attempts at their unauthorized use
    - A procedure must be in place for initial and periodic testing of devices that generate password information to ensure that they function properly

**6. What are the organizational requirements of FDA 21 CFR Part 11?**

There are five major categories that Part 11 organizational requirements fall under. Here’s a breakdown of each of them: 

1. 1. 1. *Validation:* To ensure that all elements of your system work as intended, regular system software validation checks must be conducted, and their results should be recorded.
            2. *Audit trail:* Every creation, modification, or deletion of any record should be automatically stored in an audit history file. This documentation should be retained for a period and needs to be available for FDA auditors to review and copy if required.
            3. *Operational controls:* The documents and data your company manages need to follow a [workflow structure](https://docxellent.com/document-control-solutions/version-control/). This means that your records are created, reviewed (if needed), and approved by specified personnel. Steps cannot be skipped over or worked around, and the entire process should be documented.
            4. *Training:* All users with access to your [document management system](https://docxellent.com/document-control-solutions/document-control-software/) should have [thorough training](https://docxellent.com/document-control-solutions/training-management/) and experience to currently perform their assigned tasks. This training must be documented and provable to an auditor.
            5. *Electronic signatures:* As one of the most common ways of reviewing and approving electronic records, electronic signatures show proof of your workflow process. To be compliant a digital signature must contain the printed name of the signer, the date and time when the signature was completed, and the meaning associated with the signature.

**7. Can I purchase a compliant application or solution?**

Yes, you can! There are plenty of software providers that deliver the functionality needed to help you become 21 CFR Part 11 compliant. Before deciding on a system, it’s important to do your research and ensure that their processes align with your [compliance goals](https://docxellent.com/compliance/).

**8. How do I choose the right Document Control Software that is compliant with FDA 21 CFR Part 11?**

The first and most important step in finding the right FDA-compliant Document Management Software (DMS) is to ask each vendor for a line-by-line [FDA compliance matrix](https://docxellent.com/compliance/fda-21-cfr-part-11/). This chart will show exactly how this software complies with the various subparts of 21 CFR Part 11, including their [cloud environment](https://docxellent.com/managed-cloud-services/). You’ll be able to examine each vendor’s regulatory fulfillment to make sure they’re the right fit for you before you waste time doing more research.

Any computer system that stores company data or is used to make decisions about quality must be compliant with 21 CFR Part 11. However, certain systems can make the compliance process easier than others. FDA guidance on software for electronic records and signatures is very broad, which gives different software providers the opportunity to tackle compliance in their own way. Therefore, certain vendors offer more benefits than just helping you avoid regulatory risks, such as better collaboration, smarter document control, or better data security. When looking at document control vendors, research not only how they can help you reach compliance, but also how they can benefit your overall business process.

To help make your DMS search easier, download our 6 Must-Ask Questions Before Choosing a DMS Provider guide here: 

[![Download the PDF](https://no-cache.hubspot.com/cta/default/2674727/275e6481-dcb2-4dbe-9345-63a925ef1c6a.png)](https://cta-redirect.hubspot.com/cta/redirect/2674727/275e6481-dcb2-4dbe-9345-63a925ef1c6a)

**9. Where can I find a 21 CFR Part 11 Compliance Checklist?**

To help your company navigate the compliance process, we’ve created a comprehensive 21 CFR Part 11 checklist. It includes each area of business the FDA inspects so you don’t miss a thing when preparing your processes. Check it out here: [21 CFR Part 11 Compliance Checklist](https://info.docxellent.com/21-cfr-part-11-checklist?_ga=2.32757302.983142073.1661528410-2040081377.1661528410)

As professionals in regulated industries continue to shift away from traditional, paper-based solutions within their business, it’s imperative that they address rules and regulations outlined by FDA 21 CFR Part 11. Without this standard, effectively managing records and other content electronically becomes unpredictable, leading to a significantly increased risk of human error, operational costs, and time-to-market.

Check out our other resources on FDA 21 CFR Part 11 Compliance:

- [5 Tips for Improving the FDA Audit Process](https://info.docxellent.com/blog/5-tips-for-improving-the-fda-audit-process)
- [How to Address Electronic Signature Compliance](https://info.docxellent.com/blog/fda-electronic-signature-compliance)
- [How Version Control Software Helps You Stay FDA Compliant](https://info.docxellent.com/blog/version-control-fda-compliance)
- [Abiding by FDA Regulations with Quality Management Software](https://info.docxellent.com/blog/abiding-fda-regulations-quality-management-software)
- [SaaS vs. PaaS: The Best Option for FDA Software Validation](https://info.docxellent.com/blog/paas-vs-saas-providers)

With the help of [ENSUR Document Control Management](https://docxellent.com/products/ensur-document-management-system/), you can easily prepare your electronic files to meet FDA standards, boost efficiency, and increase collaboration. To learn more, [contact us](https://docxellent.com/company/contact-us/sales/) today.

[![Get More Info About Document Management Software](https://no-cache.hubspot.com/cta/default/2674727/eab08c88-15d2-4986-8043-4551e94d0015.png)](https://cta-redirect.hubspot.com/cta/redirect/2674727/eab08c88-15d2-4986-8043-4551e94d0015)

 Tags: [FDA Compliant Document Control Software](https://info.docxellent.com/blog/topic/fda-compliant-document-control-software), [Compliance](https://info.docxellent.com/blog/topic/compliance), [fda guidelines](https://info.docxellent.com/blog/topic/fda-guidelines), [fda cfr part 11](https://info.docxellent.com/blog/topic/fda-cfr-part-11)

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