The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...

Increased regulatory focus on data integrity violations in GxP inspections opens opportunities for pharma companies to invest in staff training and compliance strategies related to document management ...

This seminar presents a market opportunity for professionals and businesses needing to enhance their understanding of FDA compliance, particularly in computer system validation. It focuses on risk ...

BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, ...

As emphasis grows on managing data in pharmaceutical labs and plants—collecting and storing it, sharing it, mining it for pertinence—a basic question often goes unanswered: Is the data any good? The ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

Explore opportunities by adopting CSA principles beyond their intended focus, ensuring alignment with Part 11, data integrity, and QMS. Learn transition from CSV to CSA with detailed steps and address ...

The market has opportunities in comprehensive training for computer system validation, particularly in regulated industries. Key areas include mastering FDA regulations, agile vs. waterfall ...

In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity failures in transit, and the FDA's ...