Description
Signatures—or, more precisely, dated signatures—are the central element of documentation through which all documentation and documents receive the authorization required by all quality (management) systems in accordance with Good Documentation Practice. At the same time, signatures are also essential for many activities in our daily lives (correspondence, signing contracts, and much more).
Due to digitalization in all areas of our lives, the traditional, manually executed signature (“wet ink signature”) is increasingly being replaced by electronic alternatives. This applies both in regulated quality systems and through requirements in generally applicable laws, such as EU Regulation (EU) No. 910/2014.
The aim of the seminar is to present the concept of the dated signature within the framework of GxP- or ISO-regulated quality (management) systems, both in its traditional form as a manual signature and in its electronic form as an electronic signature. The latter will be presented in the context of the requirements of U.S. 21 CFR Part 11 and European Regulation (EU) 910/2014, and its implementation in quality management systems will be explained using examples.
Who should attend this seminar?
- Employees of all quality (management) systems (GxP-regulated or ISO-standard-regulated) who wish to learn about or deepen their understanding of the use of dated signatures
- Employees who are responsible for defining rules for handling signatures within their organizations, such as quality managers, IT managers, and employees in leadership positions
Learning Objectives
After the seminar
- You are familiar with the significance and use cases of dated signatures in quality (management) systems.
- You have learned about the regulatory requirements for signatures in regulated quality (management) systems.
- You have fully understood the rules for handling wet ink signatures.
- You have learned about the concept of electronic signatures.
- You have become familiar with the legal regulations governing electronic signatures (21 CFR Part 11 and (EU) 910/2014) and the different levels of electronic signatures they define.
- You have reviewed a plan for implementing electronic signatures in your organization, which will make them equivalent to handwritten signatures.
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