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Veeva R&D Summit, Europe

June 12-14 | Barcelona

NNIT is exhibiting and presenting at Veeva R&D Summit 2018.

Veeva R&D Summit is an annual gathering of pharma, biotech and medical devices & diagnostics leaders in clinical, regulatory, quality, and IT.​ The agenda will have dedicated tracks focused on driving end-to-end business processes across product development.

Read more about the conference here.

NNIT's Kianoosh Khaksar will be presenting in the Quality track with the presentation: “Data Integrity: A Holistic Approach".

While data quality and data integrity are related, they are independent: you can have one without the other. Increasingly, regulators have a focus on data integrity, latest with MHRA's guidance on GxP data integrity (March 2018), where requirements to data's life cycle are made explicit.

However, requirements to data quality are just as important, but not so explicit - even good practice descriptions like GAMP does not define data quality. Yet, most pharma companies struggle with data quality issues and the consequences may be severe, both in terms of internal complications and regulatory compliance.

This talk will therefore discuss the requirements to data quality as a quality management activity in pharma and the value that it gives. The talk will discuss the considerations of data quality controls such as governance boards as well as the technology elements that enable the company to lift the data quality across the IT systems – and maintain this state.

It will highlight a couple of cases of data with data integrity, but low data quality and vice versa, in order to highlight the differences and how quality management activities best can handle them to support business value and regulatory compliance.

 

 

Nicoline Liu Poulsen+45 3077 8562nlpo@nnit.comMarketing Consultanthttp://www.linkedin.com/in/nicoline-liu-poulsenNicoline Liu Poulsen

 

 

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