Energy & Utilities
NERC Compliance Software ASSURX ECOS ENABLES NERC COMPLIANCE, IDENTIFIES RISK, AND TRACKS ACTIVITIES ACROSS YOUR ORGANIZATION AssurX Delivers Compliance Solutions for Constantly Changing [...]
How to Use the 8D Method for Investigations
Each day, quality leaders run across all types of problems. Fortunately, some can be corrected immediately. However, others need further investigation, such as a 5 Why analysis. Furthermore, there are [...]
How to Automate Food and Beverage Quality Management
Data buried in file cabinets. Forgotten emails. Poorly documented processes. Unfortunately, these practices are not uncommon in food and beverage companies. As a result, poor food and beverage quality [...]
How to Simplify CAPA Management with a Cloud-Based QMS
Corrective and preventive action (CAPA) violations are the most frequently cited non-compliance in FDA 483 inspection observations. In 2020, nearly 200 violations were cited among medical device manuf [...]
How COVID-19 Is Driving the Shift from Paper to Cloud QMS
When COVID-19 hit in 2020, companies around the world suddenly found themselves at the mercy of processes designed for the previous era of manufacturing. Not surprisingly, cloud QMS became a priority [...]
Connecting Your Document Control System for Employee Training Management
When companies implement an enterprise quality management system (EQMS), one of the first places they often start is with a corrective action solution. This makes business sense when the compelling ev [...]
All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality management systems is becoming the international standard for streamlining the r [...]
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postponing most onsite visits to limit COVID-19 risks. The number of FDA warning letters [...]
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, with manufacturing orders reaching a three-year high in February 2021, according to the Institute of Supply Management ( [...]
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the assumption that they must document and validate each and every software used in their processes. The concern was that i [...]
