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Implementation of Qualified Electronic Signatures
GxP
Introduction
Why is a QP interested in QES?
Electronic Signatures
Certificate-Based Signatures
Non-certificate-based Signatures
Signature Types in the European Legislation
CFR 11 Requirements
Signature Concepts in the Pharmaceutical Industry
What e-Signature tools should be used for
Pharmaceutical companies are non-compliant
How can pharmaceutical companies become compliant?
Introduction of QES at Roche Pharma AG Grenzach (RPAG)
Costs of QES
Benefits of QES and paperless office
Why is a QP interested in QES?
Electronic Signatures
Certificate-Based Signatures
Non-certificate-based Signatures
Signature Types in the European Legislation
CFR 11 Requirements
Signature Concepts in the Pharmaceutical Industry
What e-Signature tools should be used for
Pharmaceutical companies are non-compliant
How can pharmaceutical companies become compliant?
Introduction of QES at Roche Pharma AG Grenzach (RPAG)
Costs of QES
Benefits of QES and paperless office
Keywords, Electronic signature, Paperless Office, Qualified Electronic Signature (QES), eIDAS regulation, Non-compliance
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. |
