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Document Management System Blog

Your Guide to the Life Science CAPA Process

For companies in the life science industry, regulators require an official process for managing their corrective and preventative actions (CAPAs). Additionally, a strong CAPA workflow is necessary for audit preparation, maximizing cost savings,...

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Tags: Quality Management System, CAPA management, CAPA Workflow, life sciences

The Four Main Components of a Quality Management System

Document Control Software & Quality Plan Components

If you want to ensure you are providing consistent products or services throughout your organization, you must implement an ironclad quality management system, or QMS. Quality control management ensures that what your company delivers, and the...

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Tags: FDA compliance software, Quality Control Management, quality management, quality management software, quality management software systems

Employee Spotlight: Maddy Hemberger - Marketing Assistant

Maddy Hemberger is DocXellent’s Marketing Assistant, a dedicated runner, and a travel and adventure enthusiast. As an integral member of our Marketing team, she helps with ongoing marketing campaigns by creating content and conducting different...

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Tags: DocXellent, employee spotlight, DocXellent Employees

Top FAQs on FDA 21 CFR Part 11 Compliance

As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those...

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Tags: FDA Compliant Document Control Software, Compliance, fda guidelines, fda cfr part 11

How Medical Device Companies Can Maintain FDA 21 CFR Part 820 Compliance

For medical device manufacturers, meeting compliance standards is an essential piece of the quality process. One of the most important of these necessary regulations is FDA 21 CFR Part 820, which ensures that medical devices are safe and effective....

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Tags: FDA Compliant Document Control Software, medical device regulations, FDA 21 CFR Part 820

The ROI on a Specification Management System: Is It Worth It?

The ROI on Specification Management System: Is it Worth it?

If you’re a packaging or manufacturing professional, you’ve likely experienced the frustration of spending precious time tracking down product/packaging specification data. The manual nature of managing specifications using spreadsheets, shared...

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Tags: specification management, Spec Management, ISO 9001, Compliance

5 Tips for Complying with The FDA's Food Safety Modernization Act (FSMA)

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...

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Tags: FDA compliance software, fda guidelines, food and beverage industry, fsma

How Quality Management Helps You Adhere to ISO 9001 Standards

With consumers placing an increasingly large emphasis on product quality, meeting regulatory standards like ISO 9001 is more important than ever. To keep up with the ISO 9001 group of standards, many companies find a digital quality management...

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Tags: quality management software system, quality management software, ISO 9001, internal audit

Employee Spotlight: Joe Ciriello

Joe Ciriello is DocXellent’s Business Development Manager and resident nature enthusiast. In this development role, he works on sales expansion in the private, public, and government sectors, growing the organization one sale at a time. He also...

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Tags: employee spotlight, DocXellent Employees, document management software company, sales team

7 Steps to Improve Vendor & Supplier Management

No matter how many vendors your company works with, creating an efficient supplier management process and fostering strong relationships with them is essential. When your business success is dependent on third parties to help you deliver your...

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Tags: document management software, save money, supplier collaboration, vendor collaboration, supplier management software