On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...

Dublin, April 29, 2026 (GLOBE NEWSWIRE)-- The "Master Validation Plan for FDA cGMP Compliance - Live Online Training (June 2, 2026)" training has been added to ResearchAndMarkets.com's offering. This ...

Dublin, April 29, 2026 (GLOBE NEWSWIRE)-- The "Process Validation Guidance & Requirements Training Course (June 24th - June 25th, 2026)" training has been added to ResearchAndMarkets.com's offering.

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

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 ...

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance). 1 The 2026 guidance, which supersedes the ...

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 ...

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...