{"id":353661,"date":"2023-11-14T15:22:00","date_gmt":"2023-11-14T20:22:00","guid":{"rendered":"https:\/\/platohealth.ai\/enterprise-quality-management-software-what-you-need-to-know\/"},"modified":"2023-11-23T05:11:02","modified_gmt":"2023-11-23T10:11:02","slug":"enterprise-quality-management-software-what-you-need-to-know","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/enterprise-quality-management-software-what-you-need-to-know\/","title":{"rendered":"Enterprise Quality Management Software: What You Need To Know","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

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\"Enterprise<\/p>\n

A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries\u2014including MedTech\u2014use to ensure their products are safe and effective.\u00a0<\/span><\/p>\n

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However, the way in which a company maintains that system and its records is often anything but simple. This is especially true when it comes to enterprise companies that may easily have hundreds of products and thousands of employees in many different countries.\u00a0<\/p>\n

At that point, the types of QMS solutions that may have worked for a smaller company are no longer the best option. Enterprise-size companies require enterprise quality management software for their QMS.\u00a0<\/p>\n

BONUS eBOOK<\/strong>: Click here<\/span> to download your free copy of our eQMS Buyer’s Guide for Medical Device Companies.<\/a><\/p>\n

What is enterprise quality management software?<\/h2>\n

Enterprise quality management software is a type of software solution that large companies often use to streamline their quality processes, manage documentation, and maintain their quality management system according to relevant regulations or standards like the FDA\u2019s Quality System Regulation (QSR) or ISO 13485:2016.\u00a0<\/p>\n

In MedTech, quality management systems are shaped by ISO 13485:2016. This standard establishes the requirements for a quality system\u2014what the policies and procedures should cover\u2014but it doesn\u2019t specify the tools you should use to create or maintain your QMS.\u00a0<\/p>\n

This means that a lot of smaller companies (and some larger ones) choose to use free or low-cost tools like Excel, DropBox, or Google Drive to\u00a0 manage their QMS<\/a>. And for small companies with a handful of employees and one or two devices, this can be a workable solution for a while.<\/p>\n

But because of the complexity of operations within larger companies, an enterprise quality system can\u2019t really be maintained this way while staying on the right side of regulations.<\/p>\n

These companies need an electronic quality management system (eQMS) that can grow with them and handle both the design and development of new devices and the post-market requirements of devices already on the market.<\/p>\n

What\u2019s different about enterprise quality management software?<\/h2>\n

Enterprise quality management software is different from what smaller companies use to manage their QMS in a number of ways.<\/p>\n

Only a comprehensive solution will allow an enterprise company to eliminate the use of disconnected tools like Excel or DropBox. An all-in-one solution allows the quality management software to be woven into the fabric of a company\u2019s operations.\u00a0<\/p>\n

Enterprise companies are also different from smaller organizations in that they need quality management software that can connect quality data to other essential software tools they may be using, such as enterprise resource planning (ERP) and customer relationship management (CRM) tools.\u00a0<\/p>\n

This essentially disqualifies any disconnected, general-purpose software like Excel, Dropbox, or Google Drive. These tools can be useful in limited capacities, but for an enterprise quality system, they\u2019ll typically fall far short, creating more work than they help accomplish.\u00a0<\/p>\n

What does an enterprise quality management system include?<\/h3>\n

An enterprise QMS is a comprehensive solution. Any good QMS solution at the enterprise level will, at minimum, include features like:<\/p>\n