APIC: Update to the Data Integrity FAQs

In January 2025, the Data Integrity Task Force of the APIC Quality Group, which is 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 October 2025 again, the new version 3 has been released. It contains numerous questions on the subject of data integrity that were submitted to the Task Force by the pharmaceutical industry, along with the corresponding answers, with the updated points marked in red.

In the new version, 'Chapter 5. Record life cycle management:' has been updated. The following question about so-called 'blank forms' and its answer has been added:

Q4: If approved forms and templates that are part of a procedure are printed out of an electronic system just before use (e.g. training attendees sheets, checklists, housekeeping checklists, …), is it necessary to have controlled issuance of those templates and forms, and to have a systematic audit trail review of those printing activities?

Furthermore, the document is intended as a guide to the topic of data integrity. This means that you can always contact the task force with any new or missing points at the e-mail address provided in the document.

Version 3 of the 'Data Integrity Frequently Asked Questions (FAQ)' can be found on the APIC website under the 'Publications' tab. Here you will also find many other documents and templates related to active substances.