Description
Signatures, or rather dated signatures, are the central documentation element with which all documentation and documents receive the authorization that is required in 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 (letter correspondence, contract signatures 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 variants. Both in regulated quality systems and through specifications in generally applicable laws, e.g. EU Regulation (EU)910/2014.
The aim of the seminar is to present the dated signature in the context of GxP or ISO standard-regulated quality (management) systems, both in the conventional version as a manual signature and in the electronic version as an electronic signature. The latter will be presented against the background of the requirements of the US law 21 CFR Part 11 and the European Regulation (EU)910/2014 and the introduction in the quality (management) system will be explained with examples.
For whom is this seminar interesting
- Employees of all quality (management) systems (GxP regulated or ISO standard regulated) who want to learn or deepen their knowledge of handling dated signatures
- Employees who have to define the rules for handling signatures in their organizations, e.g. quality managers, IT managers, employees in management positions
Learning objectives
After the seminar
- know the meaning and use cases of dated signatures in quality (management) systems.
- you have become familiar with the regulatory basis for signatures in regulated quality (management) systems.
- you have internalized the rules for handling manual signatures (wet ink signatures).
- you have become familiar with the concept of electronic signatures.
- you have familiarized yourself with the legal regulations on electronic signatures (21 CFR Part 11 and (EU) 910/2014) and the different levels of electronic signatures contained therein.
- you have become familiar with a concept for the introduction of electronic signatures in your organization, making them equivalent to manual signatures.
Further information here
