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

AI in Quality Management: How Artificial Intelligence Is Revolutionizing the Quality Process

AI in Quality Management: How Artificial Intelligence Is Revolutionizing the Quality Process

Quality management is a critical aspect of various industries, ensuring that products and services meet established standards and exceed customer expectations. As technology continues to advance, the integration of artificial intelligence (AI) is...

Read more

Tags: Quality Management System, Compliance, AI, Artificial Intelligence

Mastering Quality Management in Life Sciences: 17 Essential Practices

Mastering Quality Management in Life Sciences: 17 Essential Practices

Quality management is essential in the life sciences industry to ensure the safety and efficacy of products. Whether it's pharmaceuticals, medical devices, or biotechnology, quality management systems help to establish and maintain high standards...

Read more

Tags: quality management software, Quality Management System, life sciences

7 Benefits of Implementing a Quality Management System (QMS) in 2023

7 Benefits of Implementing a Quality Management System (QMS) in 2023

7 Benefits of Implementing a Quality Management System (QMS) in 2023

As businesses continue to adapt to the ever-changing market, implementing a quality management system (QMS) has become increasingly crucial. A QMS is a system that outlines the...

Read more

Tags: Quality Management System, what is quality management system, 2023 trends

Quality Management Software (QMS) Cost & Pricing Guide

Quality Management Software (QMS) Cost & Pricing Guide

Researching Quality Management Software for your company can be a time-consuming process. Combing through multiple vendor websites to understand their product offerings, compare features, and determine which may be the best fit for your...

Read more

Tags: Quality Management System, pricing, qms

Industries Improved by a Quality Management System (QMS)

Industries Improved by a Quality Management System (QMS)

For companies of all industries, keeping the quality of your product and processes high is essential. This means that robust quality assurance is crucial in today’s business world if you want to stay competitive — not only to attract customers but...

Read more

Tags: Quality Control Management, manufacturing, Quality Management System, life sciences

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,...

Read more

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

Interview With a Quality Expert

Bobbi Lilek

Bobbi works as a Quality Systems Director for a rapidly growing biotechnology company that utilizes the ENSUR software for both Document Control and Quality Management. In order to maintain her company’s policy of strict customer...

Read more

Tags: document management software, Quality Management System, FDA Electronic Signature, Quality, audit

5 Tips to Effectively Implement a Quality Management System

5 Tips to Effectively Implement a Quality Management System

For many companies, establishing a Quality Management System (QMS) is imperative as it not only improves overall productivity and quality of products and services, but also ensures compliance. A comprehensive QMS takes a critical look at your...

Read more

Tags: quality management software system, training management, Quality Management System, CAPA management

Improve Traceability in Manufacturing with a Quality Management System

Improving Traceability in Manufacturing with a Quality Management System

What is Traceability and Why is it Important?

In the manufacturing industry traceability is defined as the process of recording necessary information which is then tracked in all business process from obtaining raw materials and parts to...

Read more

Tags: manufacturing, Quality Management System, traceability