By author > Ludivine Richard

Computerized System Validation: Access Management
Richard Ludivine  1, *@  
1 : Validation & Compliance Engineer Agidens SAS, Lyon
Agidens
* : Corresponding author

Data integrity has always been at the heart of pharma company concerns. Indeed, data generated can have a real impact on product quality and patient safety. Over the past few years, an increase in serious breaches of data integrity has been observed. This is why health authorities bring this subject to date publishing some guidances. But what is data integrity? What means are used to ensure this integrity? What should we implement? What do we avoid? How secure our data?
A large topic including computerized systems that are today key players to generate and manage data.


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