Click Here To Request A DemoClose

Document Management System Blog

Demystifying FDA CFR Part 11: A Guide for Life Science Companies

Demystifying FDA CFR Part 11: A Guide for Life Science Companies

For life science companies, compliance with regulatory standards is paramount to ensure the safety, efficacy, and quality of products and processes. One such critical regulation is FDA CFR Part 11, which governs the use of electronic records and...

Read more

Tags: FDA compliance software, Quality Management System, 21 CFR compliance, Compliance, fda cfr part 11

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...

Read more

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

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...

Read more

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

How to Prepare for and Resolve a Pharmaceutical Compliance Crisis

Is your company fully prepared to handle a compliance crisis? Effectively managing this process is no easy task, especially if you’re part of the highly regulated pharmaceutical industry. To make this process less daunting, it’s important to plan...

Read more

Tags: FDA compliance software, pharmaceutical, Compliance

How the Newest FDA Labeling Guidelines Will Affect Food & Beverage

How the Newest FDA Labeling Guidelines Will Affect the Food & Beverage Industry

The food and beverage industry faces constant regulatory challenges and is heavily scrutinized by the FDA. And with new labeling regulations coming down the pipeline, these expectations will only become more complex. In this article, we will...

Read more

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

FDA's Approach to Regulating AI Software for Medical Device Companies

FDA's Approach to Regulating AI Software for Medical Device Companies

Artificial Intelligence (AI) and machine learning are the newest technologies revolutionizing the medical device industry. These advances have the potential to transform the way medical device companies gather important insights from the vast...

Read more

Tags: FDA compliance software, medical device document control, AI, Artificial Intelligence, medical device

5 Tips for Improving the FDA Audit Process

5 Tips for Improving the FDA Audit Process

Over the last few years the Food and Drug Administration (FDA) has become progressively more aggressive and tactful in the way they conduct their audits. More often than not, companies are unprepared to manage an FDA inspection or to effectively...

Read more

Tags: FDA compliance software, quality management software system, audit, fda audit

How to Abide by FDA Regulations with Quality Management Software

Abiding by FDA Regulations with Quality Management Software

Read more

Tags: document control software, document control system, FDA compliance software, quality management software system, quality software applications, quality web document system, quality web document systems, specification management, Uncategorized, version control software, document management control, quality management software, quality management software systems, quality software application, quality web document service, training management, version control, web based document control

Docxellent Offers an Excellent Document Management Control Solution

Docxellent Offers an Excellent Document Management Control Solution

Read more

Tags: change control, cost effective document manager, document control, document control software, document control system, FDA compliance software, packaging management, quality web document system, quality web document systems, specification management, Uncategorized, version control software, custom software development, custom template design, document management control, Electronic Document Control System | DocXellent, ensur product, intellectual property control, quality management, quality management software, quality web document service, training management, version control, web based document control