APIC's Data Integrity Guide and FAQs
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In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), has published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document comprises numerous questions on the subject of data integrity the pharmaceutical industry submitted to the task force and their answers. Together with the "Practical Risk-based Guide for Managing Data Integrity" and the associated Annexes (Annex 1-4), the document provides a good support for the realisation and implementation of data integrity guidelines for the pharmaceutical industry.
This year's "27th APIC/CEFIC Global GMP & Regulatory API Conference" on 23/24 October 2024 in Vienna or live online offers interesting presentations and parallel sessions on current issues in the API industry as well as a free bound copy of the above-mentioned Data Integrity documents of the APIC Task Force to all participants. For further information on the full agenda please see the "27th APIC/CEFIC Global GMP & Regulatory API Conference" website.