5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies [...]
29
09, 2022
21
06, 2022
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the [...]
13
07, 2020
A Successful QMS Implementation Requires Clearly Defined Processes
This blog is the second of a three-part series on QMS implementation best practi [...]
1
06, 2020
How Risk-Based Testing is Revolutionizing Computer System Validation
We live in a world where speed is vital to success. Patients and consumers expe [...]
3
12, 2019
Elements of a Modern and Efficient Change Management System
An efficiently designed change management system clearly defines how strategies, [...]
18
11, 2019
Top 10 Traits of World Quality Management Leaders
It’s World Quality Month (WQM) and that means taking time to reflect and recogni [...]
31
10, 2016
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.
