Electronic Document Management Systems EDMS

Chapter 34 Case Study 16 Electronic Document Management Systems (EDMS).765... 

The most common observation made by the FDA concerns the lack of (or incomplete) audit trails. This is often associated with the incorrect identification of electronic records. Specifically, the Warning Letters referred to Chromatography Data Systems (CDS), Electronic Document Management Systems (EDMS), Databases, Batch Records, Change Records, and Device History Records. 

Document management refers to procedures or systems designed to exert an intelligent control over the creation, management, and distribution of documents. Electronic document management systems (EDMS) may include any or all of the following features ... 

The problems associated with the management of paper can be overcome by implementing an electronic document management system (EDMS). 

Artwork needs to be agreed upon between the pharmaceutical, medical device, or healthcare company and the marketing organization. Traditionally this has been achieved using fax and/or e-mail attachments. More recently the Intranet and Internet has been used to facihtate such transactions in conjunction with electronic document management systems (EDMS). 

If electronic SOPs are managed through a validated Electronic Document Management System (EDMS), it could be argued that it is not necessary to validate the intranet environment as the EDMS qualification would have effectively qualified it. The intranet would only have to be validated in its own right where its functionality is not limited to library viewing and read-only access. The qualification approach to EDMS is discussed in Chapter 34 Case Study 16. 

IS refers to the software packages and databases that provide the functionality to implement the business processes. These include such packages as Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Electronic Document Management Systems (EDMS) and Maintenance Management Systems. 

All real-time and historical information is stored on or available from the enterprise server. This can integrate information from multiple distributed applications and databases and consolidate the data into a single history system. This can then be made available as standard reports via networked printers or standard displays using Web browsers across the corporate Intranet. Copies of batch reports are written to local optical disks and also copied to the site Electronic Document Management System (EDMS) as a secondary backup and for long-term storage. 

---