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 ...

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 ...

Research and Markets has announced the addition of the "Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)" conference to their offering. Several documents ...

As most long-term care operators can attest, MDS 3.0 has spurred both opportunities and obstacles. On one hand, the new resident assessment tool is pushing resident care and satisfaction to the ...