APIC: FAQs on Data Integrity

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

In April 2023, the Task Force "Data Integrity" of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document provides numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

After the introduction, the document is divided into the following subsections:

Digital and electronic signatures
Password management
Access management
Record life cycle management
Various

Depending on the number of questions received, the individual paragraphs contain different amounts of explanations. As the document is intended to provide assistance in the area of data integrity, you can always contact the Task Force with new or missing points at the e-mail address given in the document.

"Data Integrity Frequently Asked Questions (FAQ)" can be found on the APIC website in the "Publications" tab. Many other guidance documents on the subject of active substances can also be found here.