Paperless activities

The true business value of an EDMS is realized to the extent that it serves as more than just the terminus for document-related activities in an enterprise. To fully realize its goals, an enterprise paperless documentation system will perform functions across the entire document life-cycle. In addition to the storage of existing documents, users with appropriate system privileges must be able to create new electronic documents from within the electronic document management system. The system must explicitly support the file formats used by the business, which typically include word processing, spreadsheet, graphics, and database files. 

Omit redundant paper-based activities, for example, identify certain steps and activities which are maintained for historical reasons that are no longer valid. Paperless projects conducted as full-scale Business Process Reengineering (BPR) projects typically identify many... 

In addition to the life cycle stages, supporting activities for a document must be defined, i.e., what can happen to a document at all stages of its life cycle, for example, storage, retrieval, backup, format changes and so on. This may not be inherent in a paper-based system but may need to be specified when implementing a paperless system. 

There are a number of system implementation decisions that need to be made. The computer system project will involve system requirements, project organization, the selection of suppliers, software, hardware and system network configuration, user access points and user access rights, systems integration, acceptance testing, validation and so on. These aspects of system development are discussed later in this book. Ironically, such project activities typically build up a huge pile of paper, even for projects in paperless facilities. Hopefully this situation will change. 

Active control implies that the "paper on glass" documents are no longer static. Data may be collected automatically so that only a few of the data entries are manually entered, most of them are entered through automatic data capture, possibly with a border value check and some kind of compliance enforcement. This requires a certain level of integration with physical data equipment, such as control systems, instruments, bar code readers and so on, which may prevent common errors from manual data entry and additionally provide enforcement of basic quality requirements. Active control requires the paperless system to be a true application that actively assists the user s data entry with automatic data collection and possibly interfaces to other systems. 

To date, process control systems like Programmable Logic Controllers (PLCs) have only enabled paperless operation in combination with SCADA (Supervisory Control and Data Acquisition) systems or as part of a DCS (Distributed Control System), which enable measurement and control actions to be recorded and used as part of batch documentation. Process control systems have the advantage that they focus on real-time data as a necessary part of both control and supervision. The real-time focus is very useful for implementing both active and proactive control when combined with, for example, statistical tools or predictive algorithms. 

Manufacturing Execution Systems (MES) have been subject to considerable hype on their potential for paperless production, yet these systems have proven to be some of the most difficult to use in the pharmaceutical industry. So far, only a few suppliers have been able to deliver their customer s expectations beyond initial pilot installations, and many MES implementations hardly go further than the "active paper on glass" functionality described earlier. 

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