Paperless control

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 

As mentioned in several of these focus areas, there is a need for specifying not just individuals but also their roles and responsibilities. This will be based on the representation of the organizational positions, but there is much more to 

A document will have a certain status during its life cyde, which will change with different activities. For example draft , approved , released , withdrawn and so on must be defined if they are not already standardized in a 

A separate and complex technical issue is the standardization of file formats. The configuration management issues described above and the electronic storage of documents over a long time with certainty will make previous file formats obsolete. There are two important aspects  

Software types, versions and file formats can change rapidly and significantly over time. One software vendor may guarantee compatibility between different versions of its software but only as long as the vendor exists and often only to a limited degree. In real life, the preservation of an electronic document during software updates can 

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The process drivers send status reports back via the same medium so that you have in this case achieved paperless control. 

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. 

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. 

Properly implemented paperless systems can reduce deviations during operation. Paper is a dumb medium that receives everything people record on it, but computer media have the potential of guiding or controlling operations as well as tracking deviations and errors directly during the operation. In properly implemented paperless systems, this has lead to clear deviation reductions for people, processes, materials, equipment and lead time. 

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. 

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. 

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... 

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... 

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. 

Looking further into the future, totally automated facilities loom that are truly paperless. Robotics, automated guided vehicles (AGVs), and barcode readers will be commonplace, whilst conventional operator interaction will virtually disappear. Some pharmaceutical manufacturers claim to have paperless facilities now, but in the experience of the author, they still employ a lot of paperwork (e.g., printed SOPs and work orders). Paperless facilities will bring their own set of problems, such as the use and control of electronic signatures, which is already beginning to be experienced by firms implementing... 

How many and when to order are key questions that impact on delay and inventory. JIT contributes to the answers to these questions by cutting down the sources and causes of waste in logistics. Specific contributions include the reduction of changeover times and simple, paperless systems of material control. 

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