Closed Systems are computer systems where system access is controlled by people who are responsible for the content of electronic records in the system. Most applications are considered to be closed systems.
Responsibility and Storage
The system owners are responsible for the e-records content and security. The e-records are usually stored in a repository, for example a data server.
Examples
Examples of closed systems in a regulated environment include:
- Document Management Systems
- Manufacturing Execution Systems
- Training Systems
Before we discuss each of these controls you can click the link below to view them from the FDA’s website.
Online course
5 modules
