Inside dot Archives - Dot Compliance

Quality Management System (QMS) for Medical Device

June 16th, 2022

10 min read

In this post, we will take a deep dive into the medical device quality management system, look at the principal regulations governing the QMS, the difference between a QMS and an eQMS, and how a robust eQMS can solve the regulatory quagmire for medical device manufacturers.

ICH Q10 Pharmaceutical Quality System

Core QMS

January 20th, 2022

6 min read

The stakes for quality management are high when it comes to the life science industry. As a result, pharmaceutical companies of all sizes need quality management systems built to address a slew of unique challenges and regulatory oversight. The key framework for creating a QMS that can handle the demands of the pharmaceutical industry is the International Conference on Harmonisation (ICH) Q10 model.

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Traditional QMS Solutions: 5 Reasons They Are No Longer Sufficient

Inside dot

May 10th, 2021

10 min read

How the ever-changing technology world can easily leave your business behind According to a recent study, the global Life Science market hit nearly $50 billion in 2019. It is targeted to approach $100 billion by 2027. That adds up to a compelling Compound Annual Growth Rate (CAGR) of 8.5% from 2020 through 2027. However, all...

Essential QMS Building Blocks for Emerging Life Science Organizations

Inside dot

February 2nd, 2021

4 min read

Emerging life science organizations need broad Quality Management Systems (QMS) process coverage to allow for scalable growth. Without them, drug and medical device manufacturing firms will struggle to meet quality standards and maintain their competitive advantage.

Supporting Business Continuity for Life Science companies during the Coronavirus outbreak

Inside dot

May 12th, 2020

10 min read

As the Coronavirus outbreak (COVID-19) continues to impact the business community worldwide, many companies have been forced to change the way they conduct their day to day business. Moving towards remote and virtual means as a way to address travel bans and other virus related concerns has increased dramatically making the use of various electronic...

The times, they are a changin’ for Life Science Industry

Inside dot

March 26th, 2020

10 min read

We are in unprecedented times. With the ongoing spread of COVID-19 and the incredible speed at which things are changing around us, it seems everyone needs to be able to adapt and make changes fast. Almost all forms of businesses worldwide are experiencing dramatic changes to the way they conduct business as a result of...