Deviation vs. Nonconformance: What’s the Difference?
Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab [...]
8
06, 2021
5
05, 2021
All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focu [...]
20
04, 2021
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramat [...]
13
04, 2021
Supplier Quality Management: A New QMS-Based Approach
According to research firm LNS Research, fewer than 1 in 5 companies have a robu [...]
6
04, 2021
Elements of an Effective Supplier Scorecard
Imagine if your plant is starting work on a big order. You’ve just been advised [...]
22
03, 2021
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, [...]
8
03, 2021
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the [...]
2
03, 2021
Automating Asset Change Management for NERC CIP-010 R1: Webinar
View our one-hour on demand webinar focused on the challenges of implementing a [...]
17
02, 2021
Remote Audits in the Age of COVID-19
Amid the ongoing pandemic, groups like the European Commission (EC) and the Inte [...]
9
02, 2021
EQMS Implementation: How to Lead Organizational Change
The Kübler-Ross Change Curve®, adapted from the original five stages of grief (o [...]
