Lab Safety: How QMS Software Can Prevent Costly Mistakes
Creating a culture of quality in the workplace starts with reducing the potential for human error.
ETQ Reliance 2019 Now Available
We are excited to announce the release of ETQ Reliance 2019, a major upgrade to our flagship QMS SaaS product. The latest...
4 Things Life Sciences Companies Should Know About FDA Warning Letters
The number of warning letters handed out by the U.S. Food and Drug Administration (FDA) has been on a steady rise over the...
ISO 13485 Countdown: 5 Critical Tasks to Focus on Now
The clock is ticking: in less than a year—February 28, 2019—previous ISO 13485:2003 certificates will no longer be valid....
3 Steps to Achieving Manufacturing Operational Excellence
Gartner’s five stage manufacturing maturity model helps organizations improve their manufacturing processes and supply chain...
What Does EU’s New MDR Mean for Small to Medium-Sized Companies?
As of 2020, medical device companies that market products in Europe will be subject to a much larger set of requirements...
Documentation Requirements in ISO 13485 - Start with a Quality Management System (QMS)
When it comes to ISO certifications, one thing companies can count on is a mountain of documentation.
It’s especially true...
MDR and IVDR - What Medical Device Manufacturers Need to Know About New EU Standards
Big changes are on the horizon for medical device manufacturers who market and sell their devices in Europe. On May 5, 2017...
5 Tips for Automating Your Good Manufacturing Practice (GMP) Compliance Management Processes
More and more life science companies are moving towards an automated GMP compliance management system, with the goal of...
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