Paperless system challenges

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. 

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. 

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. 

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. 

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