CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

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 ...

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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.

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "IQ, OQ, PQ in the Verification and Validation Process (Jan 28, 2026)" training has been added to ResearchAndMarkets.com's offering. This course will ...

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 ...

(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning ...