Thursday, 12 October 2023 9 .00 - 17.30 h
EMA's GCP Inspectors Working Group added a new Question & Answer No. 18 relating to Productivity Applications in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As.
Productivity applications (PAs) are software used for producing information (e.g. documents, presentations, worksheets, databases, charts). Usually they are operated locally and allow the processing of texts and tables, the extraction and combination of information from different sources and the graphical presentation of results. Usually, these applications are universal solutions, not adapted to the specific requirements of clinical trials. Thus, suppliers of these universal solutions are not considered service providers in the context of a clinical trial.
The use of PAs in areas where data integrity principles (such as the ALCOA++ principles) apply requires a risk evaluation and effective mitigation measures. If such an application is used, a justification is required and measures should be taken to ensure attributability and traceability, and to make non-traceable changes more difficult or prevent them.
For example, the specific measures could include:
Some PAs allow the user to configure and to customize the functionality of the software itself. This includes the possibility to combine certain commands, create automatic scripts or add new functions. However, these configurations and customizations should be validated before use and the scope of the validation depends on the use case and the risk for the corresponding process.
For more information please see EMA's Q&A: Good clinical practice (GCP).