Keyword Data Integrity

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:

• FDA: Data Integrity and Compliance with cGMP - Draft Guidance for Industry, April 2016
• MHRA: GxP Data Integrity Definitions and Guidance for Industry - Draft version for consultation, July 2016
• MHRA:‘GXP’ Data Integrity Guidance and Definitions, March 2018
• PIC/S: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, August 2016
• EMA: Questions and Answers: Data Integrity, August 2016

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What does this mean in practical terms?

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.

• Sampling and Sample Preparation: Sampling and Sample Preparation
• Setting up Chromatograph and Acquiring Data: Setting up Chromatograph and Acquiring Data
• Integration and Interpretation of Data: Integration and Interpretation of Data
• Calculation of Reportable Results: Calculation of Reportable Results
• Second-Person Review: Second-Person Review

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why Empower™ ?

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..

Empower ™ Data Integrity Functions at a Glance

Database Technology

• Each object is uniquely identifiable.
• Overwriting of data is not possible.
• Clear reference to which data was generated by which methods

Automated Versioning of Results and Methods

• complete electronic audit trail
• WHO changed WHEN WHAT and WHY.

Assignment of unique Ids

• Every object and every result receives a unique identification number.
• Uniqueness is given within a project.
• Changes to the objects result in the assignment of a new ID.

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Questions that we can discuss

• What data verification procedure in Empower is recommended?
• How can a secure audit of the audit trail be ensured?
• Which data should be reported in a report?
• How should the roles be defined in Empower?
• How can manipulations be revealed?
• Which approach to the validation of reports and custom fields is recommended and are there any pragmatic approaches?

and much more....