Empower 3 and data integrity

 

As a CDMO we have to anticipate and go beyond on quality and regulatory topics. We are engaged in using reliable tools (such as Empower 3) in daily use. It’s an unavoidable part of our company culture.

Empower 3 allows acquisition, processing and editing of chromatographic analysis results. Data are stored and secured according to Data Integrity regulations. The purpose of controlling chromatographic data in the laboratory is to guarantee the relevance of the results.

 

Why using Empower 3 ?

 

The purpose of using this easily adaptable software is to store and manage chromatographic data according to current authorities recommendations. We are able to control several chromatographic systems in an automatic way. We don’t need to enter the data manually, everything is done automatically. This ensures that the data recorded corresponds exactly to reality, that there is no alteration of these data and data traceability.

Each user has its own interface and can easily find previous tests. This type of tool reassures customers and increases confidence in laboratory data. This tool is part of our commitment to GMP and quality. All our employees are sensitive to this data traceability.

« Empower 3 allows us to control UPLC, HPLC, GC chromatographic systems. It is a guarantee of quality, in adequacy with the Data Integrity and allows the follow-up of the audit trail. » said Christophe Berland, Project Manager at Skyepharma.

This software is fully integrated in our data traceability process. We’re working on Data Integrity of all other processes at the laboratory to make sure we do the right analysis and secure all the results. We do our best to satisfy customer requirements.

To learn more about our capabilities in Quality Control testing laboratory, visit the dedicated page here.

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