Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
This duct-tape approach might pass an audit today, but it won’t survive the rigor of future scrutiny, nor the growing ...
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 ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
In today’s world, companies in the pharmaceutical manufacturing sector and beyond have to become increasingly aware of the scrutiny of their data. Due to rapidly evolving business models, ...
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