--- title: 6 Tips to Help Guarantee Pharmaceutical Regulatory Compliance description: Regulatory professionals in the pharmaceutical industry are tasked with keeping up with changing expectations to avoid losses & fines. Learn our tips here! image: https://info.docxellent.com/hubfs/6%20Tips%20to%20Help%20you%20Guarantee%20Pharmaceutical%20Regulatory%20Compliance%20(2)-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) - 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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. 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/) # 6 Tips to Help Guarantee Pharmaceutical Regulatory Compliance February 07, 2022 ![6 Tips to Help you Guarantee Pharmaceutical Regulatory Compliance (2)](https://info.docxellent.com/hs-fs/hubfs/6%20Tips%20to%20Help%20you%20Guarantee%20Pharmaceutical%20Regulatory%20Compliance%20(2).png?width=810&name=6%20Tips%20to%20Help%20you%20Guarantee%20Pharmaceutical%20Regulatory%20Compliance%20(2).png) Pharmaceutical companies are hit year after year with strict regulations and shifting expectations from government organizations. In fact, the number of warning letters administered during failed FDA audits has steadily increased over the last few years. According to [reported data](https://www.fda.gov/media/135046/download), in 2018 the organization had delivered 439 compliance warnings; in 2021 that number exceeded 650. Regulatory professionals in the pharmaceutical industry are tasked with keeping up with these changing expectations to avoid business losses and hefty fines for their company. In this article, we’ll provide six tips to help you ensure regulatory compliance for your organization. Read on to learn more. 1. **Identify The Regulations That Apply to Your Company** Before you can prepare for regulatory requirements, you need to be aware of the ones that apply to your company. As a pharmaceutical company, you are likely under the guidance of FDA CFR Title 21. However, to see your organization’s unique requirements, you can take a look at the FDA’s [Title 21 of the Code of Federal Regulations](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm) to determine the exact classification your products fall under. In addition to these specific CFR requirements, the FDA requires pharma companies follow current good manufacturing practices (CGMP). This is defined as: “The regulations provided by the FDA that guide the design, monitoring, and maintenance of pharma facilities and processes.” To learn more about these specific requirements, take a look at this article from the FDA: [Facts About the Current Good Manufacturing Practices (CGMPs).](https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps) Research what is required of your company, so you don’t over-prepare or miss crucial steps. 1. **Put Together a Regulation Team** Once you’re aware of every regulation your company needs to prepare for, it’s time to put together a team to tackle your regulatory process. Keeping up with regulations can be extremely time consuming. Therefore, you need a dedicated task force so you don’t put yourself in a position to fall behind. Once this team is assembled, they should first look at the potential risks your company faces when trying to meet your regulatory expectations. List potential difficulties, perform internal audits, and keep your organization aware of the types of regulatory requirements you face. These risk assessments should be routinely updated, keeping in mind that regulations are ever-changing. Ensure this team is adaptable and up to date with the [shifting pharma landscape](https://info.docxellent.com/blog/how-to-leverage-artificial-intelligence-in-the-pharma-supply-chain) so you help alleviate some risk of falling short on regulation requirements. 1. **Keep Communication Open Throughout Your Organization** To successfully meet government regulations, you need to make sure compliance is a part of your organization’s culture. To accomplish this, your employees need to be aware of, and thoroughly educated on, the various FDA obligations. Break down each regulation into smaller pieces, narrowing them down to specific job requirements. This way employees at any level with any job description know how they fit into the larger regulation puzzle. In order to successfully meet your regulatory needs, educating your team and getting your entire organization on the same page when it comes to compliance is a requirement. Developing a training matrix is one of the easiest and most organized ways you can assist in these communication efforts. A matrix will help you establishing employee groups by department/job title and allow you to marry that information with SOPs, policies, and actual [training curriculum](https://docxellent.com/document-control-solutions/training-management/) per job title. This can easily be done using a spreadsheet. **[![Click Here to Download DocXellent’s Auditor-Approved Training Matrix Template](https://no-cache.hubspot.com/cta/default/2674727/5573cf6e-2eca-46a7-af92-fc8721adfd57.png)](https://cta-redirect.hubspot.com/cta/redirect/2674727/5573cf6e-2eca-46a7-af92-fc8721adfd57)** 1. **Establish Clear Audit Trails** Setting up a process to accurately track the path of your files and documents is the next step in mastering the regulatory process. These paths, called [audit trails](https://docxellent.com/compliance/fda-21-cfr-part-11/), allow you to view which user performed any given action to your records. You can see if records were created, edited, or deleted and view when this action occurred. By maintaining complete digital records of your processes, you can demonstrate to an FDA auditor that your company’s commitment to quality and accuracy. Even further, you can respond to an auditor’s request for any document or record at a moment’s notice. Essentially, audit trails ensure that if a regulatory organization is ever questioning your company’s regulatory strength you can prove compliance. In the even that an auditor or inspector is not provided with traceable actions, 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 to keep an accurate audit trail system. The easiest way to do so is generally through the use of a [Document Management System (DMS) with quality control capabilities](https://docxellent.com/document-control-solutions/quality-management/). We’ll talk about that a little later. 1. **Prepare for and Keep Up with Software Validation** Another part of [meeting compliance requirements](https://info.docxellent.com/blog/how-to-prepare-and-resolve-pharmaceutical-compliance-crises) is to ensure every software you utilize is fully validated. The validation process consists of checking that a software system meets specifications and requirements so that it fulfills its intended purpose. So, if your company uses a software to oversee your manufacturing processes, or organize documents and audit trails, you need to keep up with that system’s validation. Unfortunately, validation can often be extremely complicated and hard to keep track of, especially as it concerns legacy systems, on-premises software systems, or software which has been heavily customized to meet an organization's requirements. If a system you use contains a considerable number of complicated codes or custom integrations with other systems, you will most likely constantly face functional issues or complexities each time you have to update the software or resolve a security issue. Therefore, before choosing any type of software, be sure to research how the system will be validated not only at the time of installation, but also during operation, performance, and the periodic revalidation process that is included in the change control procedure. Choosing systems with cloud FDA compliance capabilities is often the best choice, as these systems generally include a simple revalidation package within their client services. With [the cloud](https://docxellent.com/products/ensurcloud/), instead of compliance being a constant burden for your company, the regulatory stress will be placed entirely on your vendor. This allows you to focus on your bigger business goals and leave 21 CFR Part 11 validation concerns to the people who know the ins and outs of the requirements. 1. **Utilize a Validated Document Management System (DMS)** In today’s confusing regulatory climate, investing in a [validated Pharma Document Management System (DMS)](https://info.docxellent.com/blog/pharmaceutical-document-control) is the best option to keep your company up to date on its compliance requirements. With an adept DMS, the issue of muddied communication, inaccurate audit trail tracking, and complicated software validation is resolved. Here are some of the [major benefits of a DMS](https://info.docxellent.com/blog/4-benefits-moving-cloud-based-solution): - - - Enables full traceability across your product lines, allowing you to easily track who oversees a document, where it is in its lifecycle, who’s accessed it, who’s printed it, and who is responsible for maintaining and seeing it move into production - Allows you to create your own electronic forms where you can structure data, control inputs, and easily align your different departments on standards to ensure quality and compliance - Depending on your vendor, these systems often come fully validated. This guarantees your organization will respond with confidence to any regulatory body in an audit and that you comply with every necessary regulation Without a fully validated Document Management System, it’s easy for your company to fall behind on regulatory requirements and struggle to meet compliance. Every [pharmaceutical company](https://docxellent.com/industries/pharma/) needs to successfully manage their regulatory process. While compliance in the pharma industry can be confusing, it doesn’t have to be difficult. With the steps we’ve outlined today, this process can be pain-free. If you are looking for an organization to help you improve your pharmaceutical compliance process, DocXellent can help. We are glad to advise you on how you can accomplish your goals and demonstrate how our quality management software, [ENSUR](https://docxellent.com/products/ensur-document-management-system/), can help your company meet government regulations. [Contact us](https://docxellent.com/company/contact-us/sales/) today. 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