--- title: 5 Tips for Improving the FDA Audit Process | Document Control description: The FDA has become progressively more aggressive and tactful in the way they conduct their audits. Learn our 5 tips to improve this audit process. image: https://info.docxellent.com/hubfs/5%20Tips%20for%20Improving%20the%20FDA%20Audit%20Process%20(1)-png.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/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/) [![](https://docxellent.com/wp-content/uploads/2024/01/Other-Industry-Webpage-Image-350x210.jpg)![](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/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/) [![](https://docxellent.com/wp-content/uploads/2024/01/Other-Industry-Webpage-Image-350x210.jpg)![](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/) # 5 Tips for Improving the FDA Audit Process September 08, 2020 ![5 Tips for Improving the FDA Audit Process](https://info.docxellent.com/hubfs/5%20Tips%20for%20Improving%20the%20FDA%20Audit%20Process%20(1)-png.png) Over the last few years the Food and Drug Administration (FDA) has become progressively more aggressive and tactful in the way they conduct their audits. More often than not, companies are unprepared to manage an [FDA inspection](https://docxellent.com/compliance/ensur-and-fda-21-cfr-part-820/) or to effectively respond to observations. Because of this, tackling an FDA audit can be a stressful and laborious experience. However, one thing is certain - a little prep work can go a long way. This article will discuss five specific ways your company can prepare for an [FDA audit](https://docxellent.com/compliance/fda-21-cfr-part-11/) to make the process run smoother and ensure your company is prepared. **1)** **Document Your Standard Operating Procedures (SOPs)** Having a clear, well-defined set of standard operating procedures is crucial for every company. To make the audit process easier, these SOPs should align with the regulations the FDA requires of your industry and should always be documented in one central location. This way when an audit does become necessary, your team can put together a custom-built, Policy & Procedure Manual that pulls all [SOP documents](https://info.docxellent.com/blog/pharmaceutical-document-control) into a single binder to be handed to an auditor. This Policy & Procedure Manual will also provide other pertinent information beyond just your company’s SOPs. For example, printing an overlay with details (Author, Approver, Current Date, Version, Revision History etc.) will make it easy for an auditor to quickly gain an overall understanding of your procedures, while they can also drill down into a particular SOP if needed.  **2) Thoroughly Train Your Employees** In addition to focusing on the SOP and document control aspects in preparation for an FDA inspection, you should also be sure to train your employees in all pertinent company policies and procedures. No one looks forward to an FDA inspection, but as long your team is knowledgeable and prepared, they can understand what is expected of them at each stage of the process. The first thing your training procedure should incorporate is simulated FDA examinations. Use this prep time as an opportunity to coach employees on what to say and how to interact with an auditor. You can even reach out to professional contacts who you know have already been through an FDA inspection and ask them to evaluate your readiness. Your preparation should go through every aspect of what could happen during an FDA inspection: from the moment an FDA auditor enters your office, to where to hold the inspection, to the specific roles and responsibilities of each team member. Even further, it is crucial to regularly review the standards that manage your company and ensure there are none that need to be updated. If a revision is required, update employee training concurrently and hold occasional training sessions to refresh the skills of your team. When dealing with an FDA audit, it is important to prevent complacency from overtaking your processes and to demonstrate your on-going commitment to quality to the auditor. **3) Conduct Regular Internal Audits** Internal audits are a great way to not only prepare for an FDA inspection but also ensure your company’s processes are meeting your quality standards and that you comply with any and all relevant laws and regulations. The overarching goal of an internal audit is to ensure that your company’s policies and procedures are followed and to alert you of any holes in policy compliance so that they can be resolved before they cause more serious problems. When looking for a third-party audit service provider, or when putting together your own internal auditing program, make sure that the process will be much tougher than the audit you will experience during an FDA inspection. This will ensure that when the FDA audit rolls around, your team will understand exactly what to expect and can feel relaxed knowing all of your [business processes](https://info.docxellent.com/blog/automate-training-process-clicks-button) are thorough and compliant. **4) Have Quality Management Practices in Place** Having thorough [quality management practices](https://info.docxellent.com/blog/3-step-total-quality-management-guide) in place is critical when preparing for an FDA audit. When being audited, it is essential that your company can demonstrate how you operate within government regulations. With a [quality management system](https://docxellent.com/document-control-solutions/quality-management/), employees can assign, track, and verify action items, set up training requirements, and automate workflows to ensure that non-compliance issues are eliminated  Quality management empowers decision makers to track who oversees a document, where it is in its lifecycle, who has accessed a document, who has printed it, and who is responsible for maintaining and seeing it to its conclusion. It can also help to guarantee that the highest quality business processes are followed to ensure you’re meeting the needs of customers, stakeholders and FDA requirements. Your entire quality management system can be implemented through the system to quickly and easily prove FDA compliance every step of the way. **5) Use a Document Control Software to Manage Your Processes Electronically** By maintaining complete digital records of your processes in a document control software, you demonstrate your company’s commitment to quality and accuracy. With your documents and product data in a secured electronic repository, you can respond to an auditor’s request for any document or record at a moment’s notice. Make sure to implement a proven system for electronic data and document management to maintain data integrity. The use of a [document control system](https://docxellent.com/document-control-solutions/document-control-software/) also gives your company the advantage of version control. During an audit, it is very likely that there may be a need to show appropriate review procedures of draft documents. Therefore, it is important that review signatures and comments be paired to the document they are related to. It is not enough to just have a record of what is happening within your company; you must provide regulatory authorities with accurate, legible, original, consistent, and attributable records upon request.  This complex process requires a formal [version control system](https://docxellent.com/document-control-solutions/version-control/) within the organization. If an auditor or inspector is not provided with traceable actions, test, and resolutions of errors and deviations, validation status is often looked at as suspect. So, in order to meet regulations and remain compliant in the eyes of these authorities, you need an [electronic document control process](https://info.docxellent.com/blog/document-control-regulatory-changes) that includes version control capabilities. **How Can ENSUR Help?** FDA audits can be time-consuming and stressful for your whole team. Luckily, using a [Document Management Software](https://docxellent.com/products/ensur-document-management-system/) like ENSUR can help you tackle this process painlessly. With our document control and quality management features, you can organize all of your company’s documentation digitally – this includes standard operating procedures and all employee training material. So, when your company is facing an inspection, all of your important information is right at your fingertips. [Request a demo](https://docxellent.com/request-demo/) today to find out more about how ENSUR can make the FDA audit process easier for your company. 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