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Implementing an Electronic Document Management System Course Excerpt: This course has been designed for the pharmaceutical, medical device, and biotech industries. It includes specific details about using EDM technology to improve GMP, GLP, and GCP compliance. It also focuses on designing the EDM system to meet FDA regulatory requirements for electronic records retention, electronic signature use, and computer system validation. The intended audience is an EDM selection / project team that is implementing an EDM system for an application such as Electronic Master Records (EMR), SOP development and distribution, manufacturing deviation tracking, analytical methods database, or training records. The training gives participants "real world" information that they can use immediately to evaluate, select, and deploy an EDM system for this type of application.
The example above is a summary slide from a section of the EDM course where the project teams are challenged to develop strategies to determine the success of their own projects. Prior to seeing this slide, the participants have discussed the features and functions of several EDM systems, and have seen a demonstration of a typical system. While discussing this slide, the instructor reviews several of the "features and benefits" of EDM systems that have been discussed in the previous sections. The instructor then synthesizes these points into the measurable evaluation criteria ("key" criteria) for EDM projects that are shown here. Methods for gathering performance information are discussed, along with the participants' estimates for acceptable and exceptional results against these proposed criteria. |
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