--- title: 5 Tips to Comply with The FDA's Food Safety Modernization Act description: We've seen many changes to the FDA’s Food Safety Modernization Act (FSMA) to prevent food borne illnesses. See our tips to ensure you are complying. image: https://info.docxellent.com/hubfs/5%20Tips%20for%20Complying%20with%20The%20FDAs%20Food%20Safety%20Modernization%20Act%20(FSMA)%20(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) - 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[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. 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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 Complying with The FDA's Food Safety Modernization Act (FSMA) July 18, 2022 ![5 Tips for Complying with The FDAs Food Safety Modernization Act (FSMA)](https://info.docxellent.com/hs-fs/hubfs/5%20Tips%20for%20Complying%20with%20The%20FDAs%20Food%20Safety%20Modernization%20Act%20(FSMA)%20(3).png?width=1215&name=5%20Tips%20for%20Complying%20with%20The%20FDAs%20Food%20Safety%20Modernization%20Act%20(FSMA)%20(3).png) According to recent data from the Centers for Disease Control and Prevention, about 48 million people in the U.S. get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. The recent changes to the FDA’s Food Safety Modernization Act (FSMA) are working to change these statistics. In this article, we’ll be outlining exactly what the FSMA includes and giving you five tips on how to make compliance simple. Read on to learn more. **What is the Food Safety Modernization Act?** The FSMA was signed into law over ten years ago on January 4, 2011, launching a new era of food safety regulation. The regulations under FSMA’s umbrella aim to transform the United States' food safety system by shifting the focus from responding to foodborne illness to preventing it. As the act evolved, the FDA eventually landed on seven final rules for the implementation of modern food safety prevention practices by those who grow, process, transport, and store food. ![The 7 FSMA Rules](https://info.docxellent.com/hs-fs/hubfs/The%207%20FSMA%20Rules%20(4).png?width=1800&name=The%207%20FSMA%20Rules%20(4).png) ***1. Foreign supplier verification program (FSVP)*** The Foreign Supplier Verification Program applies to importers of human and/or animal food into the United States. It requires distributors to perform certain risk-based activities to check that imported food meets applicable U.S. safety standards. ***2. Produce safety*** The produce safety regulation establishes minimum standards for food safety practices such as growing, harvesting, packing, and holding food for human consumption. This food safety law covers farms that provide products that can be consumed in their raw state. ***3. Protection against intentional adulteration*** This rule is concerned with “preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.” All the facilities covered by this regulation must develop a protection plan that includes a vulnerabilities assessment, mitigation strategies, production monitoring, corrective actions, and verification. *** 4.* *Sanitary transportation*** The sanitary transportation rule requires food and beverage companies to develop and sustain preventive controls for potential hazards and contaminants that may occur along the transportation process. It requires organizations to fulfill transportation standards such as temperature regulations, vehicle conditions, and other good manufacturing practices. *** 5.* *Accredited third-party certification*** This regulation outlines “the framework, procedures, and requirements for accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification bodies seeking accreditation.” Certifications provided by third-party accreditors serve as evidence of quality and can be used as proof of eligibility for the Voluntary Qualified Importer Program. ***6. Preventive controls*** This rule requires food producers to have a food safety plan implemented that includes a comprehensive hazard analysis program and comprehensive, science-based preventive controls for these standards. ***7. Voluntary qualified importer program (VQIP)*** This program helps participating importers, that pay a user fee and meet eligibility criteria, import their products to the U.S. with greater speed and predictability. Requirements for safe food certifications under the VQIP ensure that the importer adheres to the food safety regulations of the country. The FDA has an FAQ page dedicated to VQIP – you can find that and more information on the program [here](https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip). **How Can Your Company Simplify FSMA Compliance?** With the seven FSMA rules outlined, let’s take a look at five tips to make meeting these regulations simple. 1. **Perform an internal food safety audit** The first step toward meeting FSMA compliance is to conduct a thorough food safety audit. Internal audits are a great way to prepare for an FDA inspection as well as ensure your company’s processes are meeting regulatory quality standards. The best way to perform an audit like this is to follow an FDA Good Manufacturing Practices (GMP) audit checklist, which includes nine parts: ![Good Manufacturing Practices (GMP) audit checklist](https://info.docxellent.com/hs-fs/hubfs/Good%20Manufacturing%20Practices%20(GMP)%20audit%20checlist%20(3).png?width=556&name=Good%20Manufacturing%20Practices%20(GMP)%20audit%20checlist%20(3).png) By inspecting these nine areas of your production, you can locate and resolve any holes in your [FSMA compliance process](https://docxellent.com/compliance/ensur-and-fda-21-cfr-part-820/) before they cause more serious problems. 2. **Implement preventative controls** Once potential risks have been identified through the audit, the next step is to establish controls to mitigate them. These controls can include things like process regulations, allergen levels, sanitation expectations, and training. Generally, these controls can be created and detailed in your company’s [food and safety plan](https://docxellent.com/industries/food-beverage-quality-management-software/). Just make sure you cover every potential risk; you don’t want to gloss over anything and have it hurt your chance of compliance down the line. 3. **Closely monitor those controls** With these controls outlined, it’s necessary to [actively monitor, verify, and validate](https://docxellent.com/document-control-solutions/document-control-software/) them as your company continues production. This is the only way to ensure your food safety plan is working the way it’s intended to. However, how you choose to track these controls is unique to each company. To ensure effectiveness, companies can measure specific parameters such as temperature, monitor an aspect of the environment, test products routinely, or find a comparable data tracking method. 4. **Document every piece of your business process** Next, be sure to track every component of your FSMA food safety plan. This includes your programs that make up the plan, proof of completion and validation, all test results, supplier documents, and [CAPAs](https://docxellent.com/document-control-solutions/capa-solutions/). The reason this is so important is to demonstrate quality when your company faces an audit. Without proof of past compliance, it’s impossible to pass a quality check. This process can be simplified with a comprehensive, cohesive [Quality Management System (QMS)](https://docxellent.com/document-control-solutions/quality-management/), which we’ll talk about next. 5. **Implement a Quality Management System (QMS)** The last step to meeting the expectations of FSMA is [implementing a QMS.](https://docxellent.com/main-components-quality-management/) When being audited by the FDA, it is essential that your company can demonstrate how you function within their regulations. With a capable quality management system, employees can make compliance simple:  - - - Assign, track, and verify action items - Set up training requirements - Track documentation: - Where it is in its lifecycle - Who’s accessed it - Who’s printed it - Who’s responsible for maintaining and seeing it to its conclusion - Utilize cloud storage to keep important documentation secure - Collect digital signatures on-site - Document and create custom workflows Your entire quality management process can be implemented through the system to quickly and easily prove FSMA compliance every step of the way before an auditor even steps in the door. The Food Safety Modernization Act is a necessary part of creating a strong global food chain and ensuring general public safety. Therefore, meeting the regulations it outlines benefits both your company and customers. Once you have determined which of the rules mentioned above apply to your business, use the five tips we’ve outlined today to make implementing the necessary procedures and safety measures for FSMA compliance simple. [Contact DocXellent](https://docxellent.com/company/contact-us/sales/) today to learn how our [ENSUR Quality Management System ](https://docxellent.com/products/ensur-document-management-system/)(QMS) can streamline every aspect of your Food Safety Modernization Act compliance. 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See our tips to ensure you are complying.", "headline" : "5 Tips for Complying with The FDA's Food Safety Modernization Act (FSMA)", "image" : "https://2674727.fs1.hubspotusercontent-na1.net/hubfs/2674727/5%20Tips%20for%20Complying%20with%20The%20FDAs%20Food%20Safety%20Modernization%20Act%20%28FSMA%29%20%282%29.png", "mainEntityOfPage" : { "@id" : "https://info.docxellent.com/blog/tips-for-complying-with-the-food-safety-modernization-act", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "height" : "60", "url" : "", "width" : "60" }, "name" : "" }, "url" : "https://info.docxellent.com/blog/tips-for-complying-with-the-food-safety-modernization-act" } ```