Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants ...

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.

DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...

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

The computer vision leader offers controlled release cloud-based software to speed up innovation for life-enhancing drugs and medical devices PALO ALTO, Calif., May 2, 2023 /PRNewswire/ -- Landing AI, ...

Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...

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, ...

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 ...