Paperless Challenges

There are some important challenges to paperless operations that can pose significant threats to the implementation of systems. The vision and the feel of urgency due to expected business benefits may lead one to underestimate the severity of the challenges involved. Several key questions have to be very carefully addressed. 

Two of the most aitical steps are scope definition and later scope control. They may seem simple initially, but in real life implementation, the purpose of paperless is typically difficult to define clearly, especially as many issues that seem obvious in a traditional, paper-based business process need to be explicitly defined when established in paperless systems. Scope control as well as the project management of resources, budget and time are pitfalls where many such implementations have fallen short. 

Is There a Realistic Relationship Between the Vision and the Actual Systems Selected  

Is There a Clear Indication of the True Benefits and the Costs Involved  

Is the Organization Well Prepared and the Training Needs Clearly Understood  

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What is less clear is how, or whether, the roles of pharmacists will grow or advance. Since no significant increase in the number of practicing pharmacists can be foreseen in the immediate future to take on this increasing workload, while hopefully continuing to expand services and the delivery of pharmaceutical care, pharmacy clearly faces a major challenge. More use of better trained, certified, or even licensed technicians is one approach. More automation and computerization is another. A rapid growth in the expected use of electronic prescriptions may also allow further efficiencies—even the prospect of a paperless automated process. 

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. 

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. 

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... 

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. 

Although operator training is always a key issue in system implementation, the challenge of changing the information flow and getting people to leave their well-known papers on which everyone can write whatever is needed, and even attach yellow stickers to add further information or questions( ), is quite significant. Some parts of what the organization use to do in less formalized ways will have to be dealt with, and some of it will not make it into the paperless system. 

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