Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Real-World Quality Management Systems and Data Integrity Compliance Tactics (July 30, 2025)" training has been added to ResearchAndMarkets.com's offering ...

The FDA has intensified its focus on data integrity in computer system validation during inspections and audits, emphasizing the critical role of compliance in systems utilized across regulated ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

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 ...

Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and ...

What Is Data Integrity & Why Is It Important? (Definition & Types) Your email has been sent Data integrity ensures the accuracy and reliability of data across its entire life cycle. Learn more about ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Pharma 4.0 Focus Data Integrity by Design - Newer Approaches and Technologies to Cost Effective 21 CFR Part 11 Compliance (Aug 19, 2025)" training has ...

Randy Barrett is a freelance writer and editor based in Washington, D.C. A large part of his portfolio career includes teaching banjo and fiddle as well as performing professionally. An organization ...

BioXcel Therapeutics faces regulatory challenges after the FDA found inconsistencies in one of its clinical trial sites, jeopardizing the supplementary approval of its drug, IGALMI. BioXcel's ...