Validation of an EDMS

One of the major factors on resources and costs when implementing a GMP-compliant EDMS is validation. It permeates all stages of the implementation process, as described below. 

The project team should consist of a core team of representatives from the key project areas. This should include Information Technology (IT) to provide expertise on the EDMS and IT infrastructure, user groups to ensure the system meets their needs. Quality Assurance (QA) and Validation to assure quality. The project team should meet regularly to review quality practices and set up regular communication sessions with the wider user base to keep them aware of all facets of the project and so that critical decisions can be made in a timely manner. 

A User Requirements Specification (URS) is a very important first step because it forms the basis of the System Definition and the selection of the supplier and influences the approach to validation. It should be the mechanism by which users have the opportunity to express their needs. Dividing the needs into musts and wants provides the project team with an indication of how to weigh the requirements during supplier selection. 

Potential number of users Easy-to-use viewing tools 

Easy-to-create documents in the company s standard packages, e.g., Microsoft Word , Lotus AmiPro  

---