--- title: Which Document Control Software Supports FDA Electronic Signature Requirements? description: Learn the 21 CFR Part 11 requirements for electronic signatures and what to look for in document control software that supports FDA compliance. image: https://info.docxellent.com/hubfs/DocX%20-%20Blog%20Banners%20-%202026-2.png --- OPEN [Click Here](https://docxellent.com/request-demo) To Request A Demo![Close](https://info.docxellent.com/hubfs/Docxellent_January2018/images/close.png) - [860.887.2900](tel:8608872900) - [Help Portal](http://support.docxellent.com/) - [Blog](https://info.docxellent.com/blog) - Translate Page ![Document Management en Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)English ![Document Management en Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)English![Document Management fr Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)French![Document Management de Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)German![Document Management hi Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)Hindi![Document Management it Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)Italian![Document Management pt Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)Portuguese![Document Management ru Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)Russian![Document Management es Translations](https://info.docxellent.com/hs-fs/hubfs/Docxellent_January2018/images/blank.png?t=1532868243578&width=16&height=16&name=blank.png)Spanish Select Language Afrikaans Albanian Amharic Arabic Armenian Azerbaijani Basque Belarusian Bengali Bosnian Bulgarian Catalan Cebuano Chichewa Chinese (Simplified) Chinese (Traditional) Corsican Croatian Czech Danish Dutch Esperanto Estonian Filipino Finnish French Frisian Galician Georgian German Greek Gujarati Haitian Creole Hausa Hawaiian Hebrew Hindi Hmong Hungarian Icelandic Igbo Indonesian Irish Italian Japanese Javanese Kannada Kazakh Khmer Korean Kurdish (Kurmanji) Kyrgyz Lao Latin Latvian Lithuanian Luxembourgish Macedonian Malagasy Malay Malayalam Maltese Maori Marathi Mongolian Myanmar (Burmese) Nepali Norwegian Pashto Persian Polish Portuguese Punjabi Romanian Russian Samoan Scots Gaelic Serbian Sesotho Shona Sindhi Sinhala Slovak Slovenian Somali Spanish Sundanese Swahili Swedish Tajik Tamil Telugu Thai Turkish Ukrainian Urdu Uzbek Vietnamese Welsh Xhosa Yiddish Yoruba Zulu Powered by [![Google Translate](https://www.gstatic.com/images/branding/googlelogo/1x/googlelogo_color_42x16dp.png)Translate](https://translate.google.com) - [![Facebook Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/fb.jpg)](https://www.facebook.com/pages/DocXellent/1452806894967432) - [![Twitter Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/tw.jpg)](https://twitter.com/DocXellent) - [![Linkedin Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/in.jpg)](https://www.linkedin.com/company/mystic-management-systems-inc.?trk=company_name) [![DocXellent Document Control Management Logo](http://docxellent.com/wp-content/themes/docxellent-site/library/images/DocXellent-Logo.png)](https://docxellent.com) - [Products](https://docxellent.com/docxellent/products/) - [ENSUR](https://docxellent.com/products/ensur-document-management-system/) [![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/) [![Corrective Action and Preventative Action](https://docxellent.com/wp-content/uploads/2017/09/CAPA-350x210.jpg)](https://docxellent.com/document-control-solutions/capa-solutions/) #### [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/) [![Document Control Management Software](https://docxellent.com/wp-content/uploads/2017/09/Document-Control-350x210.jpg)](https://docxellent.com/document-control-solutions/document-control-software/) #### [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/) [![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/) [![](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)](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)](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)](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)](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/) [![](https://docxellent.com/wp-content/uploads/2024/01/Other-Industry-Webpage-Image-350x210.jpg)](https://docxellent.com/industries/other/) #### [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/) [![ENSUR Document Management Services and Support](https://docxellent.com/wp-content/uploads/2014/04/ervices-support_782208-350x210.jpg)](https://docxellent.com/service-support/document-control-software-support/) #### [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/) [![ENSUR Document Management Services and Support](https://docxellent.com/wp-content/uploads/2014/04/ervices-support_782208-350x210.jpg)](https://docxellent.com/resources/) #### [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/) [![ENSUR Document Management System Features](https://docxellent.com/wp-content/uploads/2017/09/ENSUR-Features-350x210.jpg)](https://docxellent.com/company/about-us/) #### [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/) [![DocXellent Team Photo](https://docxellent.com/wp-content/uploads/2019/11/Teamphoto-350x210.jpg)](https://docxellent.com/team/) #### [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/) [![Document Control Customers and Partners](https://docxellent.com/wp-content/uploads/2023/11/customers-and-partners-350x210.jpg)](https://docxellent.com/company/customers-partners/) #### [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) [![Document Management Software News](https://docxellent.com/wp-content/uploads/2018/05/blog-and-announcements-350x210.jpg)](https://info.docxellent.com/blog) #### [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/) [![DocXellent Document Management White Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/logo-white.png)](https://docxellent.com) - Navigation - - [Products](https://docxellent.com/docxellent/products/) - [ENSUR](https://docxellent.com/products/ensur-document-management-system/) [![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/) [![Corrective Action and Preventative Action](https://docxellent.com/wp-content/uploads/2017/09/CAPA-350x210.jpg)](https://docxellent.com/document-control-solutions/capa-solutions/) #### [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/) [![Document Control Management Software](https://docxellent.com/wp-content/uploads/2017/09/Document-Control-350x210.jpg)](https://docxellent.com/document-control-solutions/document-control-software/) #### [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/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)](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)](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)](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)](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/) [![](https://docxellent.com/wp-content/uploads/2024/01/Other-Industry-Webpage-Image-350x210.jpg)](https://docxellent.com/industries/other/) #### [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/) [![](https://docxellent.com/wp-content/uploads/2014/04/ervices-support_782208-350x210.jpg)](https://docxellent.com/service-support/document-control-software-support/) #### [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/) [![](https://docxellent.com/wp-content/uploads/2014/04/ervices-support_782208-350x210.jpg)](https://docxellent.com/resources/) #### [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/) [![ENSUR Document Management System Features](https://docxellent.com/wp-content/uploads/2017/09/ENSUR-Features-350x210.jpg)](https://docxellent.com/company/about-us/) #### [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/) [![DocXellent Team Photo](https://docxellent.com/wp-content/uploads/2019/11/Teamphoto-350x210.jpg)](https://docxellent.com/team/) #### [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/) [![Document Control Customers and Partners](https://docxellent.com/wp-content/uploads/2023/11/customers-and-partners-350x210.jpg)](https://docxellent.com/company/customers-partners/) #### [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 and Announcements](https://info.docxellent.com/blog) [![Document Management Software News](https://docxellent.com/wp-content/uploads/2018/05/blog-and-announcements-350x210.jpg)](https://info.docxellent.com/blog) #### [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/) # Which Document Control Software Supports FDA Electronic Signature Requirements? September 30, 2026 *A practical guide to the 21 CFR Part 11 criteria your e-signature workflow must meet, and how to evaluate the systems that claim to meet them.* For quality teams at FDA-regulated organizations, adding an electronic signature to a document is only part of the equation. 21 CFR Part 11 electronic signatures must meet specific requirements designed to ensure electronic records and signatures are trustworthy, reliable, and generally equivalent to their paper counterparts. That makes the software behind the signature important. The right document control software must provide the technical controls needed to support Part 11 compliance while fitting into the review, approval, and change control processes your team already manages.  ## **What Makes Document Control Software Part 11 Compliant?** When you must meet [FDA electronic signature requirements](https://docxellent.com/compliance/fda-21-cfr-part-11/), the right software is one that enforces Part 11 controls for e-signatures, including unique user credentials, signature manifestations, record linking, and secure audit trails, all within a validated system. But there is an important distinction: the FDA does not certify individual electronic systems or methods for obtaining Part 11-compliant electronic signatures. Organizations are responsible for determining which requirements apply and implementing appropriate system controls, validation, and procedures.  ## **What Does 21 CFR Part 11 Require for Electronic Signatures?** - When electronic signatures are used under Part 11, key requirements include: • Unique electronic signatures: Each signature must be tied to one individual and cannot be reused or reassigned. - Two distinct identification components: For example, user ID and password. - Signature manifestations: These must show the signer’s printed name, the date and time of signing, and the meaning of the signature, such as review, approval, or authorship. - Signatures linked to their records: That way, they cannot be copied, removed, or transferred. - Audit trails: These must be secure, computer-generated, and time stamped.  For organizations operating under EU GMP requirements, EU Annex 11 carries comparable expectations for electronic signatures. ## **Where Common Electronic Signature Systems Can Fall Short** SharePoint add-ons, shared drives, and emailed PDFs often lack enforced signature meaning, record linking, or complete audit trails.   Standalone e-signature tools, on the other hand, may capture a signature but may not connect it to document version control, training, or change control. For quality teams, those gaps can mean more work establishing who approved what, which version was current, and what happened over time, increasing audit risk.  ## **What to Look for in Part 11 Compliant E-Signature Software** When evaluating Part 11 compliant e-signature software, look beyond signature capture. Make sure your software offers: - Built-in Part 11 e-signature controls, not a bolt-on - Signatures embedded in review, approval, and change control workflows - Full audit trails across document, user, and training activity - Validation support, such as IQ/OQ/PQ documentation - Configurability to match existing SOPs without custom code ## **How ENSUR Supports 21 CFR Part 11 Electronic Signatures** [ENSUR](https://docxellent.com/products/ensur-document-management-system/)brings the controls needed to support Part 11 compliance directly into your existing quality workflows. Electronic signatures are built into automated review and approval routing, with enforced version control and complete audit trails to maintain traceability. ENSUR also connects document control and training management, so training acknowledgments stay tied to SOP changes. ENSUR is available in a validated GxP cloud environment with IQ/OQ/PQ documentation support or as an on-premises deployment. And because [workflows can be configured](https://info.docxellent.com/blog/change-process-management-simplifies-compliance) to match your existing SOPs without custom code, quality teams get the controls auditors expect without taking on enterprise QMS cost or complexity. The impact extends to audit preparation, too. One regulated global manufacturer reduced audit preparation time by more than 90% after moving to ENSUR. If you’re evaluating document control software for an FDA-regulated organization, ENSUR can help you bring electronic signatures, document control, audit trails, training, and quality workflows together in one configurable system built to support your compliance requirements. [Request a demo today](https://docxellent.com/request-demo/) to see how ENSUR can support your quality team.  ## **Frequently Asked Questions About 21 CFR Part 11 Electronic Signatures** Does SharePoint meet 21 CFR Part 11 requirements on its own? No, SharePoint on its own does not provide all the controls needed to meet 21 CFR Part 11 requirements. Organizations using SharePoint for regulated electronic records and signatures need to evaluate and configure additional controls for areas such as electronic signatures, audit trails, access, and validation. Is a digital signature the same as a Part 11 electronic signature? No. Under 21 CFR Part 11, an electronic signature is a computer data compilation used as the legally binding equivalent of an individual’s handwritten signature. A digital signature is a specific type of electronic signature that uses cryptographic methods to verify the signer’s identity and the integrity of the data. Does FDA approve or certify e-signature software? No. FDA has stated that it does not certify individual electronic systems or methods for obtaining Part 11-compliant electronic signatures. Organizations must evaluate the system they use and ensure applicable Part 11 requirements are met. Do e-signatures need to be validated? The system supporting them may need to be validated. Part 11 includes requirements for system validation, while FDA guidance explains that the agency exercises enforcement discretion with respect to certain Part 11 requirements. Organizations should also consider any applicable predicate-rule requirements.    *Sources* - Full regulation 21 CFR Part 11, Electronic Records; Electronic Signatures: [https://www.ecfr.gov/current/title-21/part-11](https://www.ecfr.gov/current/title-21/part-11) Section 2 citations (21 CFR Part 11) - 11.1 Scope (electronic signatures as equivalent to handwritten): [https://www.ecfr.gov/current/title-21/part-11/section-11.1](https://www.ecfr.gov/current/title-21/part-11/section-11.1) - 11.10 Controls for closed systems (audit trails, validation, access controls): [https://www.ecfr.gov/current/title-21/part-11/section-11.10](https://www.ecfr.gov/current/title-21/part-11/section-11.10) - 11.50 Signature manifestations (name, date and time, meaning): [https://www.ecfr.gov/current/title-21/part-11/section-11.50](https://www.ecfr.gov/current/title-21/part-11/section-11.50) - 11.70 Signature/record linking: [https://www.ecfr.gov/current/title-21/part11/section-11.70](https://www.ecfr.gov/current/title-21/part11/section-11.70) - 11.100 General requirements (unique to one individual): [https://www.ecfr.gov/current/title-21/part-11/section-11.100](https://www.ecfr.gov/current/title-21/part-11/section-11.100) - 11.200 Electronic signature components and controls: [https://www.ecfr.gov/current/title-21/part-11/section-11.200](https://www.ecfr.gov/current/title-21/part-11/section-11.200) - 11.300 Controls for identification codes and passwords: [https://www.ecfr.gov/current/title-21/part-11/section-11.300](https://www.ecfr.gov/current/title-21/part-11/section-11.300) - Subpart C, all electronic signature requirements in one view: [https://www.ecfr.gov/current/title-21/part-11/subpart-C](https://www.ecfr.gov/current/title-21/part-11/subpart-C) - Part 11, Electronic Records; Electronic Signatures, Scope and Application (September 2003): [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part11-electronic-records-electronic-signatures-scope-and-application](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part11-electronic-records-electronic-signatures-scope-and-application) - EU Annex 11  EudraLex Volume 4, Annex 11: Computerised Systems (current version): [https://health.ec.europa.eu/system/files/2016-11/annex11\_01-2011\_en\_0.pdf](https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf) Tags: [document control software](https://info.docxellent.com/blog/topic/document-control-software), [quality management software](https://info.docxellent.com/blog/topic/quality-management-software), [Electronic Signature](https://info.docxellent.com/blog/topic/electronic-signature), [Compliance](https://info.docxellent.com/blog/topic/compliance), [audit readiness](https://info.docxellent.com/blog/topic/audit-readiness), [21 CFR Part 11](https://info.docxellent.com/blog/topic/21-cfr-part-11), [FDA](https://info.docxellent.com/blog/topic/fda) Search for: - There are no suggestions because the search field is empty. ### Subscribe to Email Updates Recent Popular Categories ### Recent ### Popular ### Categories - [Uncategorized (40)](https://info.docxellent.com/blog/topic/uncategorized) - [document management software (33)](https://info.docxellent.com/blog/topic/document-management-software) - [document management system (25)](https://info.docxellent.com/blog/topic/document-management-system) - [DocXellent Employees (22)](https://info.docxellent.com/blog/topic/docxellent-employees) - [Quality Management System (22)](https://info.docxellent.com/blog/topic/quality-management-system) - [employee spotlight (18)](https://info.docxellent.com/blog/topic/employee-spotlight) - [document control (17)](https://info.docxellent.com/blog/topic/document-control) - [specification management (17)](https://info.docxellent.com/blog/topic/specification-management) - [Compliance (16)](https://info.docxellent.com/blog/topic/compliance) - [Document Management Systems (15)](https://info.docxellent.com/blog/topic/document-management-systems) - [cyber security (15)](https://info.docxellent.com/blog/topic/cyber-security) - [quality management software (13)](https://info.docxellent.com/blog/topic/quality-management-software) - [document control software (12)](https://info.docxellent.com/blog/topic/document-control-software) - [manufacturing (12)](https://info.docxellent.com/blog/topic/manufacturing) - [pharmaceutical (12)](https://info.docxellent.com/blog/topic/pharmaceutical) - [Our Products](https://docxellent.com/products/) - [ENSUR](https://docxellent.com/products/ensur-document-management-system/) - [ENSUR Features](https://docxellent.com/products/ensur-features/) - [ENSUR Cloud](https://docxellent.com/products/ensurcloud/) - [Case Studies](https://docxellent.com/products/case-studies/) - [Solutions](https://docxellent.com/document-control-solutions/) - [CAPA](https://docxellent.com/document-control-solutions/capa/) - [Change Control](https://docxellent.com/document-control-solutions/change-control/) - [Document Control](https://docxellent.com/document-control-solutions/document-control/) - [Version Control](https://docxellent.com/document-control-solutions/version-control/) - [Deviations & Complaints](https://docxellent.com/document-control-solutions/deviations-complaints/) - [Packaging Management System](https://docxellent.com/document-control-solutions/packaging-management/) - [Quality Control Management](https://docxellent.com/document-control-solutions/quality-management/) - [Specification Document Management](https://docxellent.com/document-control-solutions/specification-management/) - [Training Management](https://docxellent.com/document-control-solutions/training-management/) - [Compliance](https://docxellent.com/compliance/) - [FDA and ENSUR Document Control](https://docxellent.com/compliance/fda-21-cfr-part-11/) - [FDA Compliant With ENSUR](https://docxellent.com/compliance/ensur-and-fda-21-cfr-part-820/) - [ISO Document Management with ENSUR](https://docxellent.com/compliance/iso-9001/) - [Industries](https://docxellent.com/industries/) - [Biotech](https://docxellent.com/industries/biotech-document-management/) - [Food and Beverage](https://docxellent.com/industries/food-beverage-quality-management-software/) - [Laboratories](https://docxellent.com/industries/laboratories/) - [Medical Devices](https://docxellent.com/industries/medical-device-document-control/) - [Pharmaceuticals](https://docxellent.com/industries/pharma/) - [Other](https://docxellent.com/industries/other/) - [Technologies](https://docxellent.com/ensur-technology/) - [Overview](https://docxellent.com/ensur-technology/overview/) - [Technical Requirements](https://docxellent.com/ensur-technology/technical-requirements/) - [3rd Party Integrated](https://docxellent.com/3rd-party-integration/) - [Services and Support](https://docxellent.com/service-support/) - [Consulting](https://docxellent.com/service-support/consulting/) - [Custom Development](https://docxellent.com/service-support/custom-development/) - [ENSUR Support](https://docxellent.com/service-support/system-support/) - [ENSUR Training](https://docxellent.com/service-support/system-training/) - [Software Quality Assurance](https://docxellent.com/service-support/software-quality-assurance/) - [Software Validation Services](https://docxellent.com/service-support/validation-services/) - [Resources](https://docxellent.com/resources/) - [Company](https://docxellent.com/company/) - [About Us](https://docxellent.com/company/about-us/) - [Mission](https://docxellent.com/company/mission/) - [Customers and Partners](https://docxellent.com/company/customers-partners/) - [Our Difference](https://docxellent.com/company/our-difference/) - [Careers](https://docxellent.com/company/career-opportunities/) - [Privacy Policy](https://docxellent.com/privacy-policy/) - [Terms of Service](https://cordance.co/docx-tos-us/) - [Blog](https://info.docxellent.com/blog) - [Client Portal](http://support.docxellent.com/) - [Contact Us](https://docxellent.com/company/contact-us/) - [Sales](https://docxellent.com/company/contact-us/sales/) - [Support](https://docxellent.com/company/contact-us/support/) **Tel: [860-887-2900](tel:8608872900) | Fax: (860) 859-1631 |** **257 Main Street Norwich, CT 06360 |** Copyright © 2018 DocXellent | [Digital Solutions by Zero Gravity Marketing](https://zerogravitymarketing.com) - [![Facebook Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/fb.jpg)](https://www.facebook.com/pages/DocXellent/1452806894967432) - [![Twitter Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/tw.jpg)](https://twitter.com/DocXellent) - [![Linkedin Logo](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/in.jpg)](https://www.linkedin.com/company/mystic-management-systems-inc.?trk=company_name) - [![Gray Google Plus Image with White Icon for Docxellent](https://docxellent.com/wp-content/themes/docxellent-site/library/images/new/gp.jpg)](https://plus.google.com/u/4/b/117231096128623351322/117231096128623351322/about?hl=en) ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "DocXellent", "url" : "https://info.docxellent.com/blog/author/docxellent" }, "dateModified" : "2026-09-30T19:29:41.128Z", "datePublished" : "2026-09-30T19:29:06.000Z", "headline" : "Which Document Control Software Supports FDA Electronic Signature Requirements?", "mainEntityOfPage" : { "@id" : "https://info.docxellent.com/blog/which-document-control-software-supports-fda-electronic-signature-requirements", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://info.docxellent.com/hubfs/docxellent-web-1.png" }, "name" : "DocXellent" } } ```