Paper-based operations

The paper-based operation is based on a split between execution and approval of operational steps in the pharmaceutical environment. Paper is an unintelligent medium. The real execution steps are separated from the approval steps that cause both a delay in time and a supervision of the production status, which is far from real time and can lead to a bottleneck in the production process. 

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. 

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. 

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. 

In this example, the user would record on paper each significant step in the operation. The retention and protection of the paper-based record(s) is based on the retention requirements that can be found in the applicable predicate mle. 

In this case, reports are paper-based. The operator/user may record each significant step of the computer-related operation and/or critical outputs. Paper records and associated electronic records are retained, based the requirements of the applicable predicate rule. In hybrid systems, one approach to the signature/records linkage is by referencing the file(s) as part of the report. The reference may include the name, and creation date and time of the files associated with the batch report. Modifications to any referenced electronic file will invalidate the approval of the associated batch report. 

Analogous to today s paper-based environment, companies must be able to make requested data available within a reasonable period (typically a few hours for on-line data, and between 24 to 48 h for archived data). This is achieved by displaying the data on screen or by printing it out. As a rule, databases are usually more able to meet the individual requirements of inspectors than is currently the case with paper-based filing systems. However, because the systems used can only be operated in accordance with their specifications, it cannot be assumed that they will be able to answer every conceivable query. For each individual case, it must, therefore, always be clarified... 

As detailed earlier, offset lithographic printing operates on the principle that oil and water do not mix. With paper-based materials, conventional inks usually dry by oxidation and absorption. Early screen inks were also based on oil, drying by oxidation. These were used to achieve a thick film of 20-30 Pm. Thinner inks were obtained by the use of non-nitrated cellulose derivatives, modified resins and white spirit. Ultra-thin film inks were subsequently introduced which gave films between 5 and 10 Pm, thereby enabling the use of half-tone images. 

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. 

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. 

Furthermore, computers have now become a much more "rich" medium than paper ever was. Within the last 10 years of development of the Graphical User Interface (GUI), the technology has evolved from a mere "what you see is what you get" (WYSIWYG) concept into an intelligent and multimedia-based environment. Today s computer systems can replace papers in the streamlined operation and incorporate a much more functional and intuitive way of describing process activities and outputs. A rapid development of standard systems interfaces, including Web technology, has enabled systems to contain more automatic updates and much more intuitive information access methods than the paper-based medium ever could. 

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... 

Links to information are provided (equipment integrity and safety information) are provided. The h5 perlink will take the operator to relevant documents such as engineering data sheets or MSDS. With a paper-based system the practical difficulties of finding such information means that the operator is less likely to make the effort to go look for it... 

Uses Antifoam for aq. systems, foods, fermentations, distillations, scald baths for poultry defeathering, hog dehairing, food-contact paper/pa-perboard defoamer for starch recovery and modification, starch-based operations, animal feed, food pkg. adhesives, food-contact paper coatings... 

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