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.

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, ...

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 ...

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 ...

This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA.

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 ...

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 ...