Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

The wheels of medical device regulation turn slowly at times. But just like The Little Engine That Could, it usually reaches its destination eventually. One of the slowest moving regulations was FDA's ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year. The list of draft documents touches on many topics ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

MAPLE GROVE, Minn., June 22, 2023 /PRNewswire/ -- ZEISS is now offering customers validation solutions for their ZEISS Coordinate Measuring Machines (CMMs). The validation of quality assurance systems ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.