Recommendation on Electronic Signatures by the Association for Pharmaceutical Technology

The International Association for Pharmaceutical Technology (APV e.V.) has published a guidance document on Electronic Signatures. The content is based on a risk-based top-down approach according to the predicate rules. This excellent document, written by several experts, covers an analysis for different regulated areas, like GMP, GLP, GCP, API Production, and medical devices . Also the detailed analysis includes aspects on rules from the FDA, the German Signature Law, and Europe. Hence it is a very useful and complete conclusion and guideline for a regulatory compliant validation approach. Unfortunally this document is only available in German language:

Download link: http://www.apv-mainz.de/pdf_publikationen/Elektronische%20Signaturen%20V1.pdf

APV Homepage: http://www.apv-mainz.de/englisch/apv/wuu/