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Annex 11 & Part 11 Computerized Systems, Electronic Records and Electronic Signatures — Scope and Application
The European Commission (CE) issued the GMP with Annex 11: Computerized Systems. The FDA issued the Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application. These guidances try to give directions in relating to computerized systems/electronic records and electronic signatures. There are differences in the two guidances in their scope and their requirements.
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Issues to be covered
This seminar describes the following:
- Understanding the basic terminology of Annex 11 and 21 CFR Part 11
- Determining which systems in your organization that need to comply with this ruling
- Understanding the difference between 21 CFR Part 11 and Annex 11
- Understanding HIPAA as compared to Annex 11 and Part 11
- Looking into document control systems
- Understanding what are electronic submissions
- Knowing what your options are and where you should be going
About The Lecturer
