Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramat [...]
20
04, 2021
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 [...]
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 [...]
3
02, 2021
Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software
AssurX Platform Automates Document Management and Training Management; More Proc [...]
21
01, 2021
EU MDR Countdown: What’s Next for Medical Device Compliance
In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]
19
01, 2021
Addressing the EU MDR and IVDR Certification Bottleneck
With the May 26, 2021 implementation deadline looming for the new EU Medical Dev [...]
