At the LOUNGES 2017 conferences in Stuttgart, executive editor Thomas Peither spoke with the GMP inspector Dr. Petra Rempe from the regional government in Münster (Germany) during a GMP Talk about the highly topical subject of data integrity. Last week, in LOGFILE 33, you read the first part of the summary of the GMP Talk. Today, in part two, you will learn about the correlation between data integrity and quality culture, about the ALCOA principles, as well as about the definition of an audit trail.
Data integrity is a part of this quality culture. The procedures are basically the same. The com-pany needs to develop a strategy. The top management has to support it, serve as a role model and to convey the concept to their employees.
The employees need to know that data integrity is important for the quality and safety of the medicines and thus for the safety of patients. This can be achieved by training and by inspecting the system (are my processes still appropriate?) throughout the lifecycle of the medicine.
The strategic orientation of the company plays a major role in this. If the company is more business-oriented and less quality-oriented, some aspects take on a greater priority than others. A signal needs to be sent by the senior leadership that quality is the company’s highest goal. To achieve this certain instruments need to be utilized actively by the employees.
It depends how the data are connected to the higher-level systems. If the data are extracted into these systems and used for trending or continued process verification, for example, then it is necessary to ensure that the data integrity of the automation systems is maintained. During GMP inspections we only address this level in individual cases.
The WHO guideline defines the essential characteristics of paper-based and electronic data according to the ALCOA principle. The abbreviation ALCOA comes from:
On the topic of contemporaneous data it is important that the data are recorded in a manner which preserves the proper chronological order. At the latest when a process step is completed it must be protocolled. During an inspection the inspector may review the current batch record closely, for example. If the equipment has been running for a while already and the line clearance hasn’t been documented yet, this can give reason to start asking questions.
Another example is a batch record that had been signed, but there was no entry for the time point. In this kind case suspicions arise, whether the chronology of the events is to be entered later.
The “Plus” covers the additional principles of CCEA. CCEA stands for complete, consistent, enduring and available. These “Plus Principles” are related to the ALCOA principles. So ALCOA Plus can be understood as an extension of the interpretation.
Audit trails serve to enable the tracing of users and projects and the documentation that users have not made unauthorised changes. It is important that the audit trail remains complete and has been validated.
I would compare it more with an online diary for the data. It describes points such as: Who is logged in to the system? Who has done what? Using which access level? What was the initial status? What was the raw data? How did I process them? What was the result? What did I do with it then?
Yes, you are right, that is a very sensitive topic. The audit trail has to be reviewed periodically by authorised persons. And also, GMP inspectors are allowed to review them as well.
The authorities would take legal steps in cases where massive data leaks have occurred, for example if the Qualified Person had released a batch in spite of the gaps in the data. In this case the QP would be personally responsible and would have to bear the consequences.
Dr. Sabine Paris
Maas & Peither AG – GMP Publishing