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EMA: Q&A Annex 11 Computergestützte Systeme
Die folgenden Themen werden behandelt:
- Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets?
- Which type of accuracy checks (Annex 11 p 6) are expected for use of spreadsheets?
- Are there any specific considerations for the validation of spreadsheets?
- Which measures are required to ensure data security of databases?
- At which phases of the system lifecycle risk management is recommended?
- Are user requirements needed as part of the retrospective validation of legacy systems?
- When do I have to revalidate computerised systems?
- What are the requirements for storage time of electronic data and documents?
- Which are the relevant validation efforts for small devices?
- What alternative controls are accepted in case a system is not capable to generate printouts indicating if any of the data has been changed since the original entry?
Was ist zu tun?
Lesen Sie die Antworten der EMA auf die oben genannten Fragen und prüfen Sie, ob diese Anforderungen auf Ihr System zutreffen.
Quelle:
EMA/ Q&A