Description
Signatures, or better dated signatures, are the central documentation element with which any documentation and documents receive the authorization that is required in all quality (management) systems according to Good Documentation Practice. At the same time, signatures are also centrally required 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 variant as a manual signature and in the electronic variant as an electronic signature. The latter will be presented on the background of the requirements according to 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 the handling of 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 as well as use cases of dated signatures in quality (management) systems.
- you have learned the regulatory basis for signatures in regulated quality (management) systems.
- you have internalized the rules for dealing with manual signatures (wet ink signatures).
- you have learned about the concept of electronic signatures.
- you have become familiar 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 learned a concept for the introduction of electronic signatures in your organization, making them equivalent to manual signatures.
More information here
