Paperless system other

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. 

E-mail is probably the most widespread ready-made application where electronic signature can be used and is used. Work flow and document management applications are other examples of information systems where an electronic signature is needed. Those applications are mainly dedicated to closed communities of users and documents with a limited validity period. The paperless office is the type of application that may be most promising for coming years. 

It might be beneficial to discuss some of the current wisdom about the relative merits of paper-based and paperless documentation systems. Some of the claims about the outright superiority of electronic-based systems are perhaps overstated and highly context-dependent. Others probably have as much merit as their face value would seem to indicate. Table 1 provides a summary inventory of the pros and cons of the two models for document management. 

Replace paper with a different medium, e.g., computers, which is what people typically have in mind when talking paperless. The immediate example is simply to transfer procedures and documents in a paper-based operation into screens and reports in a computer system, but it can also be the replacement of some procedures and instructions by drawings, video clips and other electronic media which replace the paper. 

Thus planning for paperless operations today poses the challenge of empowering operators with a much better insight to the process, the required operational sequence and the related information than would ever be possible in the paper-based world. Computers can make use of information resources and description methods other than the traditional text to bypass many of the previously mentioned problems of instruction through written procedures. Modern computer systems not only streamline the information flow but also improve the understanding and quality of operations to be executed. Trend displays may provide an overview that no paper-based system comes close to, and embedded video clips may describe operations in a way that even the best written procedure could never achieve. This not only... 

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. 

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. 

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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