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 ...
According to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on data integrity and compliance with CGMP, the FDA issued their ALCOA definition of ...
The quality of correctness, completeness, wholeness, soundness and compliance with the intention of the creators of the data. It is achieved by preventing accidental or deliberate but unauthorized ...
Mike Chapple is associate teaching professor of IT, analytics and operations at the University of Notre Dame. Data integrity took center stage for federal officials in 2014 as Congress subpoenaed the ...
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, ...
For all systems which store, process, and retrieve data – such as thermal analyzers – data integrity is paramount. “Data integrity is the degree to which data are complete, consistent, accurate, ...
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 ...
When designing a system an architect must conform to all three corners of the CIA (Confidentiality, Integrity and Accessibility) triangle. System requirements for data confidentiality are driven not ...
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 ...
Data tells us who our best customers are, which staff members perform well and how to improve efficiency in our businesses. Companies need this data to make the right decisions about their current and ...
Data is the great enabler when it comes to manufacturing processes. But not all data is good. Industry pundits estimate that about 85 percent of the data generated in manufacturing has absolutely no ...