In 2016, different drug agencies issued updated darft guidelines on data integrity of computer systems. Inspectors are also becoming increasingly familiar with the Empower ™ software as it is one of the most widely used chromatography data systems in the pharmaceutical sector. Due to the timeliness of the topic, there is an increased demand for support on this topic also for Empower ™. Here I can substantially assist with my background of experience background.
You can find the latest versions of the relevant guidelines here:
There is already a wealth of literature covering the topic of data integrity for the chromatography lab in the GxP area. Helpful are the publications of M.E. Newton and R.D. McDowall, who appeared in a series of six articles on ChromatographyOnline in 2018, analyzing and discussing the topic for the different phases of the analytical lifecycle.
The Empower ™ software is based on a database technology. Apart from the recorded measurement signals, all data is stored in an Oracle database. With this software architecture, the applicable data integrity standards can be implemented in the best possible way..
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