Paperless Enablers

Depending on the scope of a paperless project, it is important to consider both the system strategy and the system architecture. Often, there is only a limited choice of relevant systems that meet a pharmaceutical company s IT strategies and preferred platform. Furthermore, there will often be some existing systems in place that do not support the scope of replacing paper used in daily operations. Paperless operations have in the past been used as a sales promotion feature for specific products that purport to enable paperless operation. As configurable standard systems have gained acceptance in many 

Only few years ago, system interfaces required special programs developed in a language such as Structured Query Language (SQL), C or C++ to link applications directly to each other or through interfaces of shared files or database tables. 

Web browsers and an information-aware data format that allows Web information to be processed by a computer without manual data intervention. 

It would go beyond the scope of this book to discuss the technical issues of the enabling system platforms, but it is important to bear in mind that the integration challenge of most enabling technologies will largely depend on the system platform on which they operate. Some platforms will facilitate more integration than others. 

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. 

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LIMS are an important paperless enabler in the laboratory area which contains information regarding the quality and produrt characteristics of raw materials as well as intermediate and finished drug products. Users inside and outside the laboratory may typically access LIMS information. LIMS resemble in scope MES, as they support the operation directly in the daily work perspective and are prepared for direct interfacing with most common laboratory equipment and instruments. However, LIMS are a mature and well-defined category of systems, unlike the present situation with MES. 

As LIMS typically contain both the analysis values and the associated procedures, they hold much potential for integration with other paperless enablers to provide a streamlined paperless operation. Integration with other systems may include, for example, preassignment of analysis when a new batch is started on the plant floor, material status information for MRP II or ERP systems, electronic certificates of analysis for batch documentation, raw material characteristics for dispensing operation and others. It should be noted, however, that integrating LIMS with other paperless enablers outside the laboratory environment is a complex task. 

Given these goals and objectives for paperless systems, it is perhaps helpful to look at the specific business and functional requirements that drive and enable them. 

Finally, software tools that can secure electronic records and enable safe storage of data have received considerable attention [65], These technologies allow for more streamlined approaches (i.e., electronic notebooks, paperless laboratories) and provide for the legal defensibility of patents and NCEs. 

Use the transition toward paperless systems to facilitate operator empowerment. Operators are allowed to take a broader responsibility and to use electronic media as an enabler to supervise performance and quality of their production. This enables in-line control of quality and deviations. Multiskilled, team-based working may also be introduced with the aim that broader job roles will make work more challenging and interesting. Significant lower manning levels are usually expected. All this must be achieved with due consideration of current GMP regulatory requirements. 

Today s typical pharmaceutical business has many people working with paper-based information throughout its supply chain. The operations of the future may involve fewer people, but, on the other hand, a more streamlined and dynamic operation, for which the paperless operation concept can be an important enabler, will probably be a necessary condition for business survival. 

The emergence of Web technology is a great enabler. It has given various electronic documents a uniform environment and user interface. Intranet systems will lead the way in simplifying all areas of a paperless operation as part of a transfer into Web-based systems, providing a uniform accessibility to relevant, corporate-wide, real-time information throughout the paperless operation of the future corporation. 

Paper walling is only one method among many available, but it cannot stand alone. The operation of an existing as well as a streamlined operation may be illustrated in many ways, inspired by formalized information and logistic architecture methods. The main objective of ensuring a lean and streamlined operation will have to be translated into system requirements and in turn a system design that enables the actual system to be built. A key success criterion is how well the outcome in the computer system design reflects a user-friendly and streamlined flow of operation and information in the paperless facility. 

Another important area of process control systems is the ability to handle trend curves as part of production documentation. Recent software packages (called Historians) provide such capability over an extremely long time span and with batch production facilities which enable paperless handling of batch data that should be documented by graphical trend curves. Some... 

MRP 11/ERP systems enable paperless operation within a facility and with supply chain partners (suppliers and customers). System integration standards such as EDI bring the possibility of transferring business information automatically between systems in a very secure manner, which not only replaces paper but also makes many manual operations obsolete. In combination with Web interfaces on the Internet to enable customers and suppliers to enter data directly into the business systems, the whole issue of electronic commerce with its huge implication on business processes within a company becomes an area with many important implications for paperless operation. 

LIMS are a key enabler in pharmaceutical operations for two main reasons (1) They enable paperless operation in the laboratory environment, thus handling procedures and specifications for laboratory analysis as well as laboratory analysis records. (2) They provide results and status information for materials, which enables systems in other environments such as production to close the quality loop by providing aitical feedback on the results from suppliers and the pharmaceutical company s own production processes. 

There are many more enablers for paperless operation that may be considered. Systems for maintenance, caiibration management, warehouses, transportation, test equipment and Computer-Aided Design (CAD) are just a few of the other systems of relevance within the scope of paperless operation. Some of these enabiers can be through custom developments and hence be difficult to integrate for the same reasons as described earlier. 

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