Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

PMI’s FDA-approved SynCardia STAH is promising, but adoption and revenues lag; cash burn and dilution weigh. Read the full ...

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

The SNS records neural activity from 60 channels across four brain regions—an order-of-magnitude increase over commercially ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an international ...

CAMP4 Therapeutics Corporation (NASDAQ: CAMP) on Thursday entered into a strategic research, collaboration, and license agreement with GSK Plc (NYSE: GSK). The collaboration aims to identify and ...

BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver cancer FDA Fast Track Designation reflects the potential of BGB-B2033 in an area of high unmet need ...