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A Warning Letter (or Form-483) of Inspectional Observations from the FDA is a nightmare for regulated business...
As defined by US legislation, a conflict mineral is a metal derived from one of four minerals: tantalum, tin, ...
Businesses must prioritize customer safety at all times. Even though adverse event data is valuable for improv...
COVID-19 has changed the way we work for the rest of our lives. The possibility of remote work is available fo...
Experiencing workplace incidents and its consequences is simply unpleasant. No one likes to face adverse event...
What is the Purpose of Quality Policy? Quality policies describe your company's intentions, goals, and guideli...
To be successful, your business needs to maintain quality at all levels. Managing an organization is about qua...
ISO and QMS: An Enterprises Perspective Businesses commonly standardize their processes. The standards in a pa...
Whether an organization succeeds or fails largely depends on the quality of its products and services. In the ...
The most valuable asset to your organization is its data. First, however, you need to be sure that the data yo...
Training plays a critical role in creating efficient teams that help you achieve operational excellence and bu...
The Corrective Actions and Preventive Actions (CAPA) process plays a significant role in achieving operational...