Paperless Operation

In parallel with these developments, the regulatory environment is increasingly supportive of paperless operations and record systems, provided they can be demonstrated to be equally compliant with predicate rule requirements. 

Paperless operations have been heavily promoted in recent years within the pharmaceutical industry. However, only a few companies have been successful in the transition toward paperless operations. The reasons for this are manifold. There are significant factors little of the promising technology is mature enough to facilitate a low-risk, large-scale, corporate roll-out, and the regulatory requirements of the pharmaceutical industry have raised questions on "how much needs to be done" to ensure the compliance of a paperless pharmaceutical operation. There are few published, real-life case studies that report clear financial benefits from implementing corporate/enterprise computer systems. 

As part of a highly regulated industry, pharmaceutical companies have high requirements on documentation in all important areas of their operations. All companies have realized the potential of paperless operation, not only improved control and potential cost savings but also the rest of the industrial society is rapidly evolving toward more paperless operation. 

Thus "paperless operation" is far beyond the point of being a special focus area for the pharmaceutical industry, as it has become one of the most intensively discussed focus areas in industry generally. We are moving more and more into a digital world. 

This hidden production with its execution, logistics and quality management is what the paperless operation replaces. Therefore, the hidden factory needs to be exposed—both to set the goals for the paperless operation, which should be based on a streamlined version of the existing hidden factory, and to set the benchmarking goals that are important for evaluating the business case of a paperless operation on both the cost and benefit side. 

Thus, though it may seem that the term paperless is a natural and obvious concept that has become a natural part of our highly computerized life in today s industrial society, this is really not the case. In order to describe paperless operations in the context of a corporate/enterprise computer system, it is important to be specific on what is meant with the term paperless. 

A controversial area over at least the last 20 years on the topic of implementing computer applications has been the replacement of manual jobs with computers. What are the impacts of paperless operations from an employment perspective And to be more specific Do paperless operations imply peopleless manufacturing plants ... 

The answer is typically both yes and no. Paperless manufacturing plants will not be totally peopleless plants, but most of them will have lower manning levels than traditional plants. The transition toward paperless operations should be seen as part of a larger transition throughout the industrialized... 

Roughly speaking, there are two ways of applying the benefits of paperless operations ... 

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. 

However, the consequences on the technical side of the transition to paperless operations should not be underestimated. Paperless systems are normally much more complicated to operate and maintain from the technical side than traditional equipment. Thus, an operation must expect to have more staffing of competent technical people to support the operation and maintenance of the systems and to have clearly defined maintenance agreements with their suppliers. 

The concept of paperless operations is not just an issue of replacing manual information operations with automatic, electronic operations it is a challenge of transformation toward a vastly changed organizational setup where automation no longer just replaces human labor but also provides a much more information-focused production organization. 

What makes companies go for paperless operations Paper is one of the most important cornerstones in the pharmaceutical industry today for several reasons. 

While all this and more can be said about paper s insufficiencies, it must be realized that paper is not entirely avoidable. Most paper can be replaced in fact, almost all paper can be avoided, but there will still be some left. We cannot live without paper, and even so-called paperless operations have many printers. To manage paperless operations in the real world means managing a hybrid system of paper and electronic media. It is still worthwhile to call it paperless but to remember that some paper always sneaks in. 

On the other hand, the concept of paperless operations contains some promising advantages. Some of the most important attributes driving paperless operations are cost based, but there are also some other important advantages. 

When dealing with paperless operations, there are several issues that are self-evident in the paper-based world but must be dealt with specifically to ensure the control of documents in the electronic world. When implementing a paperless operation, these issues must be carefully evaluated and resolved, preferably with a standard solution aaoss an operation or whole company. It... 

The actual path that various documents must follow in the organization may or may not be fixed in a paperless operation, but it must be decided whether workflow automation is within the scope and, if so, how it should be implemented. Again, it is different from the paper-based world in that such definitions will not just be for specific persons or specific documents but on the roles of the persons and on the categories of documents. Possible workflow paths for the various document types and document phases will also need to be decided. Paperless operation may be achieved without tying electronic documents and their management to a workflow. When doing this, it is important to retain flexibility. 

In today s paperless operation, it may be necessary to keep two versions of each document—one in the portable file format (which cannot be edited) and one in the native format of the creating program (which can be edited). Future technologies may change this as the issues become important in more and more areas of society and as such technologies as Hyper Text Markup... 

The requirements of the pharmaceutical product and its effects must be documented from discovery through clinical testing to final production. Both regulatory requirements—the amount of documentation this involves—and the time-to-market pressure on the whole pharmaceutical industry have made most pharmaceutical companies very aware of the potential benefits of electronic document management and paperless operations. 

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. 

Acknowledging the advantages of paperless rather than paper-based operation, it should be realized that the benefit of a paperless operation can only be truly exploited through top-down planning, similar to the concept of BPR. An operation going paperless needs to map what the workflow is, what papers are created and how they interact. Like a BPR project, this needs to be addressed by a cross-functional effort mapping the present situation, the envisioned future and the steps to be followed to get there. 

During paper-wall sessions, the existing work and document flow can be changed to take advantage of options made available through a paperless operation. Although individual processes may be optimized, the main outcome... 

The change from paper-based operations to paperless operations may have more advantages than are immediately apparent. Computers provide an interactive medium that provides a fundamentally different way of working than the passive medium of paper. They can respond back on data entries, guide the operator and ensure d5mamic updates with up-to-date information throughout the company. 

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... 

Paperless operations may be handled in many different ways. These differ by the level of ambitions of the system and by the intelligence put into the computer system. The decisions on how far to go may be helped by a simple and pragmatic categorization of four main levels of the paperless operation. 

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... 

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. 

In the past, process control systems have been based on proprietary computer platforms, acting as "islands of information" from which production reports were printed out and stored as part of the critical production information. This situation is rapidly changing as most process control systems now operate on open standard platforms that are much easier to integrate. Recent development in control communication protocol standards has made such system integration even easier. Nevertheless, many process control systems currently used have been in operation for many years, leaving companies with the challenge of interfacing these proprietary systems in order to release the benefits of paperless operation. 

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. 

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. 

EDMS are a key component for most paperless operations as a means to store and control the use of electronic documents. As most data in the manufacturing environment are documents that can be stored as files, EDMS have a... 

Examples of EDMS are well known, but some companies have implemented similar functionality based on general groupware platforms such as Lotus Notes . This may provide a simple start-up for a simple document management project, but it lacks many of the special characteristics of genuine EDMS and may prove a complicated solution in a longer-term strategy toward paperless operation. 

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