The market opportunities lie in leveraging data process mapping to enhance data integrity and regulatory compliance, particularly aligning with FDA standards. There's potential in addressing gaps, ...

The U.S. Food and Drug Administration (FDA) has sent Royal Philips CEO Roy Jakobs a warning letter saying the devices made at three of its facilities are adulterated and fail to conform ...

Market opportunities arise from the growing need for modernization and compliance assurance in FDA-regulated industries focusing on data integrity. Emphasizing cloud computing, automation, and mobile ...

FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.

Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ensuring compliance with FDA ...

Bypassing its standard pathways for scientific discussions, FDA has recently held a slew of so-called "expert panels" that sidestep legal procedures and ethics guardrails, raising concern about cherry ...