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28 May 2008
 We invite you to read the article „E-Signatures Set the Standard – E-Signatures can improve access to documents and information sharing“.
The article „E-Signatures Set the Standard – E-Signatures can improve access to documents and information sharing“ was published in the latest issue of the Pharmaceutical Formulation & Quality magazine.
Markus Roemer, at Systec & Services responsible for the Quality Management” business unit and Peter Beach who is with PGB Consultants Ltd. have both authored this article. Together they present very illustrative the various applications of electronic signatures and both compare and differentiate these with the handwritten signature.
Furthermore the article also provides tips and hints in regards to which regulations need to be considered in the pharmaceutical (GMP), the laboratory (GLP) and the clinical studies (GCP) environment. They also compare the applicable EU and US regulations and define the basic elements of an electronic and digital signature.
What does the „Public Key Infrastructure (PKI)“ has to do with electronic signatures in the Life Sciences industry and what are the differences and implications of an electronic signature versus initials? Have you ever heard of a „Digital“, „Electronic“, and „Qualified“ Signature and if so, do you know the differences?
The electronic signature is clearly a chance but also an important and necessary element if you want to take the IT automation to the next level.
We hope you enjoy reading the entire article. If you have any questions or need further consulting please don’t hesitate to contact Markus Roemer.
Markus Roemer
Director Quality Management
Phone.: +49 721 / 6634-590
E-Mail:
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Article from Systec & Services in the Pharmaceutical Formulation & Quality magazine
