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Implementation of Qualified Electronic Signatures
GxP
IntroductionWhy is a QP interested in QES?Electronic SignaturesCertificate-Based SignaturesNon-certificate-based SignaturesSignature Types in the European LegislationCFR 11 RequirementsSignature Concepts in the Pharmaceutical IndustryWhat e-Signature tools should be used forPharmaceutical companies are non-compliantHow can pharmaceutical companies become compliant?Introduction of QES at Roche Pharma AG Grenzach (RPAG)Costs of QESBenefits of QES and paperless office
Keywords: Electronic signature | Paperless Office | Qualified Electronic Signature (QES) | eIDAS regulation | Non-compliance
Abstract
The pharmaceutical industry has developed their electronic signature concepts based on CFR part 11 requirements. Applicable EU (or also Swiss) requirements on electronic signature standards are not widely adapted, in particular the standards: Qualified Electronic Signature (QES) and Advanced Electronic Signature (AdES). This publication sheds some light on the legal and technical backgrounds and appeals to use compliant signature standards throughout the Pharmaceutical Industry in Europe. The author describes the successful implementation of Qualified Electronic Signatures at Roche Pharma AG, Grenzach.
Author: Dr. Andreas Schwinn, Roche Pharma*)
Correspondence:
Dr. Andreas Schwinn
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen
andreas.schwinn@roche.com
 | Dr. Andreas Schwinn is a Pharmacist and Qualified Person. He started his industry career at a Contract Research Organisation (CRO)/Contract Manufacturing Organisation (CMO) establishing the units Clinical Trial Supply business as a respected service provider in the field. During this time, he acquired the qualified person (QP) qualification in 2005. In 2013, he joined Roche Pharma AG as QP for investigational medicinal product (IMPs). After heading the Release Preparation Team for several years, he is now Senior QP for IMPs. |
