The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight 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 ...
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, ...
Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Data integrity is a hot topic for regulators and auditors, making it important to understand data integrity criteria for the laboratory – and apply the principles correctly. A free on-demand webinar ...
DUBLIN--(BUSINESS WIRE)--The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's offering. Document management and data integrity are a key ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback