Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
miraDry Implements AssurX Quality Management and Regulatory Compliance Software
MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leade [...]
How an EQMS can Reduce CAPA and Complaint Observation Trends
As we move through 2022, we look forward to new opportunities, new challenges, [...]
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
This article is part two of a two-part series focused on GMP quality audit manag [...]
Remote Quality Audits for Regulated Companies Come of Age
This article is part one of a two-part series focused on GMP quality audit mana [...]
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]
Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Int [...]
7 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers [...]
3 Phases of EQMS Implementation and 12 Strategies for Success
Part 3 of a three-part quality automation blog series We live in a time of rapi [...]
Making the Business Case for an Electronic Quality Management System
Part 2 of a three-part EQMS blog series If you’re responsible for establishing [...]
