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18 Apr 2016

What is the meaning of Data Integrity issue in pharmaceutical industry?

Data integrity in pharmaceutical industry is very common and indeed a subject of discussion in recent times.
Data integrity referes to incomplete records and faulty documentation in pharmaceutical manufacturing unit.
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
 
FDA expects that data be reliable and accurate. CGMP  regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models.

The global regulatory authority has also gone on to define data integrity to be complete, consistent, and accurate. This data needs to be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.

It has provided considerable focus on electronic data generated to achieve cGMP compliance. The regulatory insists on the need for relevant metadata which is defines as contextual information required to understand data.

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