Blue Mountain, the leader in GMP-compliant Enterprise Asset Management (EAM) software for life sciences, today announced the appointment of Paul Adams, CISSP, as Chief Information Security Officer ...

FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...

Blue Mountain, the leader in GMP-compliant Enterprise Asset Management (EAM) software for life sciences, today announced the latest release of RAM Connect, expanding its integration ecosystem with new ...

PAK BioSolutions today announced that a major biopharmaceutical company has successfully filed a First-in-Human (FIH) clinical trial application with drug product manufactured using the PAK ...

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced its acceptance into the U.S. Food and Drug Administration's inaugural Manufacturing PreCheck Pilot ...

The safety and sterility of injectable pharmaceuticals, vaccines, and implantable medical devices depend fundamentally on the detection of bacterial endotoxins. Even in picogram quantities, these ...

TraceLink has been named a finalist in the 2026 Fortress Cybersecurity Awards for OPUS and OPUS Agents. The recognition highlights TraceLink's ability to support agentic supply chain operations in one ...

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...

Xailient has received independent validation from Gaming Laboratories International for its edge AI facial recognition ...

Retrofitting legacy bioprocessing equipment with modern PAT tools requires targeted sensor, software, and change-control ...

Executives are making significant investment decisions based on AI outcomes they cannot independently verify. A machine ...

A comparison of eight AI-powered requirements management platforms for 2026, from NLP-based quality analysis and automated test generation to live traceability scoring, covering Jama Connect, IBM ...