APIC: Update of Data Integrity FAQs

In January 2025, the Task Force "Data Integrity" of the Quality Group of APIC, a sector group of the European Chemical Industry Council (CEFIC), published version 2 of the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. In this document, numerous questions on the subject of Data Integrity submitted to the Task Force by the pharmaceutical industry are asked and answered, with the updated points marked in red. Updated and new questions and answers can be found in the "Password management" and "Access management" sections.

Password management

The first question "When I logged into a system, do I need to re-authenticate myself for every data entry?" and its answer have been added here. Whereas the question "How do I define when a password should be entered during a specific operation when data is being recorded?" in version 1 of the FAQs has been reworded and is now phrased as follows in version 2: "What are the requirements for e-signature components?"

Access management

In this chapter, the second question "Can we extend the time of a user session before this is automatically locked for inactivity because of a HSE (health-safety-environment) concern? (e.g. people need to interact in case of emergency in a DCS-distributed control system in production)" and its answer have been added.

The document is intended to provide assistance in the area of Data Integrity. You can therefore contact the Task Force at any time with new or missing points at the email address provided in the document.

Version 2 of "Data Integrity Frequently Asked Questions (FAQ)" can be found on the APIC website under the "Publications" tab. Many other guidance documents relating to active substances are also available here.