Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program. Data integrity, which refers to the ...

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance. This article summarizes a pharmaceutical industry consensus viewpoint of the ...

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

Aside from the accuracy and validity of data, data integrity also deals with the safety and security of data wherever it could potentially be used for malicious intent, such as patient data in ...