Electronic document management environment

Version Security. In the paper world, archival documents held in a file room are in some sense final drafts. Security for a product document must be determined by its status. The electronic document management environment in which documents are managed across their entire life cycle by its very nature allows for the inclusion of draft materials. So, in addition to permitting or disallowing the viewing of the final version of a file, the electronic world must consider and secure access to draft versions. Usually, only authors, editors, and reviewers of files have access to the drafts before they are finalized. Once files are promoted to final status, this version is then promulgated to a broader readership. The draft versions, by contrast, may continue to be accessible by the authors, or may be locked or purged from the system. 

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. 

EDMS = Electronic Document Management System MMS = Maintenance Management System BMS = Building Management System RCM reliability-centered maintenance SHE = Safety, Health and Environment OEM = Operation and Maintenance CMP = Good Manufacturing Practice IQ= Installation Qualification OQ = Operational Qualification... 

As a result, electronic document and records management systems (ERMS) are becoming more and more essential in this environment in order to handle the volume of data and related documents as well as to verify the quality and the integrity of the data for FDA auditors. ERMS have become critical for research and development in the biotech and pharmaceutical industry to the extent that the FDA created... 

This expanded view of task automation includes new capabilities in the the traditional area of instrument automation and in the somewhat newer related field of robotics. In addition it includes a number of functions which are not new to the office and business environment but have only recently become readily available in the laboratory. These are tools such as data base management, scientific text processing, and electronic mail and document transfer. One way to improve technical productivity Is by giving the scientist more time to do science. This can be accomplished through improved efficiency In the office, communication, and information retrieval functions which must be performed as well as by allowing science to be done In new and more efficient ways through the use of computers. 

---