ANN ARBOR, Mich. and HAWTHORNE, Calif. (September 19, 2012) – Space Exploration Technologies (SpaceX), which designs, manufactures and launches the world’s most advanced rockets and spacecraft, has ...

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing products in the United States. Although FDA has always ...

Implementing the new standard on quality management (QM) by the Dec. 15, 2025, deadline may seem daunting, but the AICPA has developed resources and tools to get started, including a recently revised ...

The value of a quality department is reflected by its impact on quality and safety outcomes to stop harm upstream and prevent it from reoccurring. In times of budget and workforce reductions, ...

The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 ...

Businesses use quality management systems to improve the efficiency of their processes, which can help increase profitability. Total Quality Management systems use a variety of tools and theories to ...

Boeing’s processes for ensuring its aircraft are consistently built to company specifications are undergoing a major revamp—due in large part to lessons learned from 787 production-quality problems ...

LAWRENCEVILLE, Ga.--(BUSINESS WIRE)--Following nearly 30 years as the leader in lab quality management, MediaLab today announced its rebrand to Vastian, representing the company’s evolution to extend ...

Editor’s note: This article is the second in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The interrelated final standards on ...

Owners must manage capital projects well to keep costs under control and ensure a high-quality product is delivered on time. Good communication, sound procedures and processes, and high-tech tools can ...