Data integrity management at Skyepharma


Customers are of course attentive to CDMO’s compliance with regulations. But they are even more attentive to the ability of CDMO to go beyond the authorities’ expectations. Data integrity is a good example.

What do we mean by data integrity? The purpose of controlling data integrity in the pharmaceutical industry is to guarantee the robustness of pharmaceutical decisions. Indeed, a lack of control over data integrity frequently reflects a more global lack of control over product quality.

From a practical point of view, that means ensuring that the data recorded corresponds exactly to reality, that there is no alteration of these data and data traceability.

This traceability of GMP data allows us to make the right decisions and ensure patient safety by guaranteeing a safe and quality drug.


All employees are involved


At Skyepharma a specific expert working group has been set up to integrate data integrity in our processes. Apart from this expert group, all employees received appropriate training with a specific focus on data traceability. It is now fully integrated in Skyepharma values and culture.

“Data integrity process is fully assimilated at Skyepharma. This process makes it possible to easily integrate new IT systems or equipments and responds to the requirements of customers and health authorities” said Ludivine Laugerette, Head of Technical Quality Assurance Department at Skyepharma.

An exhaustive inventory of all systems and equipment has been carried out to ensure compliance. The priority systems have been processed, the other systems are being changed and integrated into the new traceability process.

This assessment allows us to meet the ALCOA+ standard (Attributable Legible Contemporaneous Original Accurate + Complete Consistent Enduring Available Data).

“This project was a very challenging one, we succeeded thanks to our team spirit and to the strong implication of all the staff. People are proud to have taken up this challenge!” Says Xavier Mathiot, Skyepharma Quality Director.

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