---
title: Addressing FDA 21 CFR Part 11 Electronic Signature Compliance
description: Compliance is a concern for big industry businesses in healthcare, medical device or laboratory. See why electronic signature compliance is crucial.
image: https://info.docxellent.com/hubfs/21%20CFR%20Part%2011.png
---

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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/)
            
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            #### [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.
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            #### [Change Control](https://docxellent.com/document-control-solutions/change-control/)
            
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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/)
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            #### [Biotech](https://docxellent.com/industries/biotech-document-management/)
            
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            Our document management software helps companies in the food & beverage industry comply with FDA audit & SQF audit control guidelines. Contact DocXellent today!
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            #### [Laboratories](https://docxellent.com/industries/laboratories/)
            
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            Our document management software can help with your medical device compliance. Contact us today for more document control information on the medical device industry.
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# How To Address Electronic Signature Compliance

May 27, 2019

![21-CFR-Part-11-Compliance](https://info.docxellent.com/hs-fs/hubfs/21%20CFR%20Part%2011.png?width=560&name=21%20CFR%20Part%2011.png)

Compliance is a top concern for businesses across industries, including healthcare, medical device, laboratories, and more. To stay compliant, organizations need to make sure multiple aspects of their operations are following regulations set forth by the U.S. government. Any technology used, tools implemented, and data stored are all elements of a business that are tightly regulated depending on the business's industry. Healthcare organizations, for example, are obliged to follow the Health Insurance Portability and Accountability Act (HIPAA), which aims to ensure that data privacy is guaranteed, and medical information is securely stored. Electronic signatures are an important component of staying compliant as businesses move paper to the digital realm.

## What is Title 21 CFR Part 11?

The [U.S. Food and Drug Administration](https://docxellent.com/abiding-fda-regulations-quality-management-software/) (FDA) established Title 21 CFR Part 11 as the regulation on electronic signatures. The law defines how electronic signatures are considered reliable and equivalent to paper records, and it applies across industries, including biotech, pharmaceutical, medical device manufacturing, and more. The [21 CFR Part 11](https://docxellent.com/compliance/ensur-and-fda-21-cfr-part-820/) title requires companies that use electronic signatures to prove that the electronic documents are authentic. For businesses that process large volumes of digital paperwork, this requirement can prove to complicate operations.

Many businesses can apply 21 CFR Part 11 because any instance of a business scanning and putting paper documentation into a digital network counts as an electronic record in Part 11. The law aims to ensure that electronic signatures are as real as paper ones. Remaining compliant with Part 11 is the responsibility of the business using electronic documents. This is where document management software comes in.

If your business has regulatory requirements to follow, one of the tools that can help you process [compliant electronic signatures](https://docxellent.com/products/ensur-features/) is [FDA-compliant document management software](https://docxellent.com/compliance/). This provides quality control software solutions that help you comply with various regulations in your industry.

## How Does Document Management Software Help You Stay Compliant with Electronic Signatures?

[Document control](https://docxellent.com/document-control-solutions/document-control-software/) is essential to stay compliant with Part 11. Document management software (DMS) provides several crucial benefits, including:

- Retaining required signatures indefinitely
- Collecting and storing required sign-offs automatically
- Storing documentation for retrieval at any time, including current and previous versions of documents and signatures
- Storing all major revisions throughout a document's life cycle

Digital signatures require using a digital certificate – an electronic key that demonstrates the authenticity of a digital instance and its information. Document management software helps securely store and manage documentation that requires these signatures and provides a full audit trail on all documents within the system.  This means that a report can be pulled showing all actions taken on a given document, when, and by whom.

Document management software also automates many manual paper processes to help:

- Ensure protection of records
- Guarantee system access is only provided to authorized individuals
- Implement the creation of audit trail documentation
- Validate systems to ensure accurate, reliable performance

DMS can also help guarantee that people who develop, maintain, and provide electronic signatures are knowledgeable about how to remain compliant through electronic training and comprehension tests.

## Stay Compliant with ENSUR

DocXellent has been providing companies in many regulated industries with a document control application that offers all the necessary controls and safeguards since 1983. We help businesses with not only 21 CFR Part 11 compliance, but 21 CFR Part 820 and a dozen other standards and regulations. Our [ENSUR document management software](https://docxellent.com/products/ensurcloud/) can be implemented on-premise for ultimate control over your document management processes, or it can be accessed through a robust, secure, and proven cloud-based installation. In either environment, your electronic signatures remain compliant with 21 CFR Part 11 and any other regulations you need to conform with so your business can rest assured of its compliance with these complicated laws.

 Tags: [FDA Compliant Document Control Software](https://info.docxellent.com/blog/topic/fda-compliant-document-control-software), [FDA Electronic Signature](https://info.docxellent.com/blog/topic/fda-electronic-signature), [Electronic Signature](https://info.docxellent.com/blog/topic/electronic-signature), [Digital signature](https://info.docxellent.com/blog/topic/digital-signature), [21 CFR compliance](https://info.docxellent.com/blog/topic/21-cfr-compliance)

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