regulations – Trevalco

September 21, 2022

Published by Joachim Nuyttens at September 21, 2022

What’s in the new Eudralex Annex 1

A few weeks back the new and final version of Eudralex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” was published on the website of the European Commission. This new version will come into operation on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. Where the current version of Eudralex Volume 4 Annex 1 is 16 pages, the new version has no less than 59 pages. The new EU annex 1 regulation provides […]

August 30, 2021

Published by Joachim Nuyttens at August 30, 2021

Audit trail requirements on GxP computerized systems

According to Wikipedia an audit trail is a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. The first uses of audit trails date back to ancient civilizations when rudimentary methods emerged to manage goods, soldiers and financial transactions. Audit trails to ensure data integrity came into the spotlight when US regulation 21CFR Part 11 was issued in 1997. Part 11 requires the use of secure, […]