---
title: How to Prepare for a Virtual Laboratory Audit | QMS Software Audit
description: Due to a rise of remote work policies, in person laboratory auditing has been less common. Learn how your laboratory can prepare for a virtual audit.
image: https://info.docxellent.com/hubfs/How%20to%20Prepare%20for%20a%20Virtual%20Laboratory%20Audit%20(1)-png.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.
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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.
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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.
    - [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 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/)
      
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      #### [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/)
      
      [![](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.
- [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/)
      
      [![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/)
      
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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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- Navigation
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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/)
            
            [![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/)
            
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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/) 
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# How to Prepare for a Virtual Laboratory Audit

June 07, 2021

![How to Prepare for a Virtual Laboratory Audit](https://info.docxellent.com/hubfs/How%20to%20Prepare%20for%20a%20Virtual%20Laboratory%20Audit%20(1)-png.png)

Due to the rise of remote work policies stemming from the COVID-19 pandemic, in person laboratory auditing has been nearly impossible over the past year. Reacting to these difficulties, the FDA [announced](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic) in March of 2020 that they would be scaling back domestic inspections and instead relying on reviewing companies remotely. In this article we’ll discuss the new trend of remote auditing, help you decide if this process is right for your laboratory, and give you some tips on how to prepare for one.

**What is a Virtual Audit?**

A virtual audit is a great tool for companies operating remotely. As the name suggests, remote audits are performed entirely online using methods such as video conferencing, email, and telephone to obtain audit evidence. These types of inspections include everything a traditional one would, just without the face-to-face contact. This allows companies to remain compliant without performing an audit in person.

**Is a Virtual Audit Right for Your Laboratory?**

The first step in the virtual audit process is determining if this type of inspection is right for your laboratory. And to do that, it is important to weigh the pros and cons of performing an inspection virtually.

**Benefits of a remote audit**

When administered correctly and properly prepared for, remote auditing can offer many benefits to your company in addition to helping you stay within regulatory standards. Let’s take a look at some of the most relevant benefits.

- - **Time and cost savings**: In the age of cloud computing, companies have the option to make their data available to stakeholders from anywhere at any time. This means that auditors and employees preforming an audit don’t need to be in an office setting to prepare or conduct an inspection. Performing an audit remotely eliminates an unnecessary commute and allows team members to take back travel time to focus on audit preparation. In addition, performing an audit remotely removes any expectation placed on your company to cover travel expenses for the auditors.
    - **Better for your records:** Because remote audits are conducted via video conferencing, you have the ability to record the auditing sessions. These videos can be kept in your company records and referenced to track your company’s progress over time.
    - **Increased security and transparency**: Utilizing [cloud technology](https://info.docxellent.com/blog/document-management-software-cloud-vs-on-premises) during your audit is a great way to ensure robust security and total transparency. In a normal in-person inspection, management and administration may not have access to the audit report. However, with remote auditing, audit reports are required to be stored in secure centralized clouds. The auditors give real-time insight, and the managers get authentic reports on their certification audits. In addition, only the customer and the auditor have access to the audit reports, ensuring the reports’ security.

**Disadvantages to a remote audit**

Although remote auditing is convenient in these unprecedented times, there are some drawbacks that your company should take into consideration.

- - **Technological barriers**: One issue that your laboratory could run into during a virtual audit is the logistics, depending on the location of each employee and auditor involved in the inspection. There can be log in issues when trying to show documentation and network connections are not always reliable. These barriers lead to interrupted meetings and lagging audit sessions.
    - **Approval from certification and accreditation bodies:** Although most regulatory bodies consider remote audits totally legitimate, not every organization does. Some have concerns about performing an entire audit without visiting the location, and certain doubts about the reduction of on-site hours that would be spent in virtual work. Therefore, it is important to investigate the organization that will be conducting your inspection to make sure they allow virtual inspections.
    - **Lack of involvement**: Virtually meeting for audit sessions can cause issues with attendance and proper prioritizing from employees. Some process managers may become unavailable because of previously scheduled meetings or lose attention and attempt to perform other tasks while the audit is being conducted. Your leadership can play a big role here, delivering awareness sessions for their employees and preparing employees with the tools necessary to be remotely audited.

While remote audits are convenient and efficient, they are not right for every laboratory. When deciding if a remote audit is right for your company, it is necessary to take these advantages and disadvantages into consideration.

**How can you prepare?**

If you decide remote auditing would benefit your company, the next step is to spend ample time preparing. While the process will be similar to the traditional inspection you’re accustomed to, there are important disparities. Here are three audit elements to properly prepare before your audit day.

**1) IT preparation**

Like mentioned earlier, technological issues can be a major barrier to conducting an efficient remote audit. That’s why it’s important to prepare your IT process as well as possible. Have your IT team identify potential problems in the project plan and make any necessary policy or technical adjustments.

In addition, don’t be afraid to have an open line of communication with your auditors. Discuss with them which online conference system and means of communication will be used and ensure that they meet your company’s cyber-security measures for confidentiality, security, and data protection. Both parties need to have proper IT and cybersecurity processes in use for your remote audit to run smoothly.

**2) Legal agreements**

Next, be sure to sign any necessary legal documentation regarding the recording of your remote audit. If your company does choose to keep a recording for your records, you will need both the consent of all participants as well as a breakdown of security protocols and conditions for storage and deletion. When seeking consent, remember to specify whether you will be recording sound, video or both. If you rely on recordings to document the findings, make sure there is a way to determine who said what.

It is also important to remember that if you and the auditor do legally agree that the sessions can’t be recorded, it is still possible for those involved to break these rules and take screenshots or capture the session in some other way. This would be a serious breach of confidentiality and security. For this reason, your remote audit requires a level of trust between the auditor and the auditee.

**3) Internal document review**

Before any audit begins, it is always necessary to gather and review the documentation you’ll need to present to the auditor. However, during a remote inspection you will obviously be showing your company data over video call, and you’ll be utilizing virtual files. For this reason, it is important to efficiently organize your documents virtually so you can pull up any data your auditor requests. In addition, determine if there is anything that needs to be sent to the auditing body ahead of the actual audit session. This preparation will help prevent unnecessary inefficiency and allow the audit to run as smoothly as possible.

Remote audits are becoming increasingly popular in the laboratory industry. It seems that this practice is here to stay due to the benefits they offer both auditees and regulatory bodies. If your company is looking to conduct a virtual audit in the near future, utilizing a cloud-based [Quality Management System](https://docxellent.com/document-control-solutions/quality-management/) (QMS) like [ENSUR](https://docxellent.com/) is the perfect way to prepare. A QMS software offers the following benefits to help your remote audit run smoothly:

- - Give secure and controlled system access to auditors from anywhere in the world
    - Validated software that complies with numerous standards & regulations
    - Track your content's compliance to regulated standards right inside the system
    - Download documents & reports instantly
    - Organize documents into electronic binders
    - Track your audit responses through action items, Incident reports

A system like this allows your company to take a proactive and transparent approach to reviewing policies & procedures, training programs, document reviews and audit responses, demonstrating your company’s dedication to quality. A [QMS](https://docxellent.com/document-control-solutions/quality-management/) software will help you quickly and confidently prepare materials needed for your virtual regulatory audit. To learn more,  [contact DocXellent](https://docxellent.com/company/contact-us/) today.

 Tags: [Compliance](https://info.docxellent.com/blog/topic/compliance), [audit](https://info.docxellent.com/blog/topic/audit), [fda audit](https://info.docxellent.com/blog/topic/fda-audit), [laboratory industry](https://info.docxellent.com/blog/topic/laboratory-industry)

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