Paperless recorders

Easy to use, automated fit testing Paperless record keeping and documentation... 

The future of the batch record is a paperless system that will record data directly from equipment (start times, weights, temperatures, fill speed, etc.) and use recognition systems such as retinal eye scans for employee signatures. For some, the future is already here in one form or another, but for the... 

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. 

FDA asserts that the benefits of electronic record keeping in reduced review time and related business costs, such as space and rapid information access, will offset the costs of compliance with the rule. (Preamble Comment XVI.C.l, p. 13463.) As industry and regulators enter the brave new paperless world, this remains to be verified. 

Finally, software tools that can secure electronic records and enable safe storage of data have received considerable attention [65], These technologies allow for more streamlined approaches (i.e., electronic notebooks, paperless laboratories) and provide for the legal defensibility of patents and NCEs. 

C. Dobbing. 2001. Paperless practice Electronic medical records at island health. Computer Methods and Programs in Biomedicine 64 197-199. 

In many laboratories, particularly (hose in (he pharmaceuii-cal indus(r>. governmen( regulations, new produc( development, product testing, and auditing have led to a substantial increase in paper vork. Because of the extensive use of computers and automated instruments in analytical laboratories, there has been discussion for many years that elec tronic, paperless laboratories could solve the problems caused by this explosion ol paperwork and record keeping. 

Until recently, paperless manufacturing operations were held back in the pharmaceutical industry because the U.S. Food and Drug Administration (FDA) did not accept electronic signatures. This obstacle was formally removed when the U.S. GMPs (Good Manufacturing Practices) were enhanced to accept electronic records and signatures under specified conditions by... 

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. 

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. 

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. 

Lab-on-a-chip analyzers, 941 Laboratory electronic, 127-130 operations, in microfluidics, 940 paperless, 127 recorders, 52 -53 LabVIEW, 99,102-103, 745 LALLS (low-angle laser light scattering), 951-955 Laminar-flow burners, 233 LAN (local area network), 105,107 LAPS (light-addressable... 

It is essential that a record be kept of how the spectrometry equipment is set up and of any adjustments subsequently made. In my opinion, each system should have a logbook opened when it is installed. Since detectors might be moved from system to system, each detector should have its own logbook kept from the moment it is received into the laboratory. In this day of the paperless laboratory , the logbook could, of course, be held on computer. However, my personal preference would be for the old-fashioned paper logbook. It can be there at hand for instant use and never needs to wait while the network server re-boots - during which time the intention to record an event can so often evaporate. There is, however, the problem of how one backs-up the logbook. 

A good illustration of the sort of issue that can face plant operators is the case of a paperless chart recorder in use at Sellafield reprocessing plant, Cumbria, UK, in the early 2000s [3], Industrial plant all over the world has for many decades nsed chart recorders, where a parameter of interest - say a temperature in a particular part of process plant - is monitored using a pen on a roll of paper. The difficulty with pen recorders was that, whenever you wanted to investigate something, it always seemed that the ink had run out, or the paper had run out. So, with the advent of microprocessors and memory chips, suppliers started to provide paperless chart recorders, where the section of paper that would normally be visible was replaced by a small LCD display, and the memory inside the instrument stored the signals for later replay if required. They were made to be the same size as old paper chart recorders so they were like-for-like replacements of the older units. They have now replaced the older paper chart recorders almost everywhere. 

However, in about 2005, operators at Sellafield nuclear reprocessing plant began to notice problems with one particular make of paperless chart recorder. They began to go to sleep or require constant re-booting. 

Eventually, it was discovered that the operating system software in the paperless chart recorder contained what programers call an Easter egg . In the factory-installed software, there was a game installed called Cave Hy . If a particular combination of buttons on its front panel were operated, the chart recorder changed to a game console. The problem was that the game caused the memory to overflow, and dumped old stored data, and also caused the whole chart recorder to start operating slowly and temperamentally. 

Software errors described in this book included deliberate acts (the paperless chart recorder), and poorly specified systems (the North Sea pipe handling system that re-set to a dangerous condition). There have also been numerous very expensive automobile recalls for software errors - however, we usually do not know whether or not these software errors led to accidents. 

A formal record is desirable for every inspection and preventive maintenance job. If the work is at all detailed, a checklist should be used. The completed checklist should be returned to the maintenance office on completion of the work. Any open preventive maintenance work orders should be kept on report until the supervisor has checked the results for quality assurance and signed off approval. Modem computer technology with handheld computers and pen-based electronic assistants permits paperless checklists and verification. In many situations, a paper work order form is still the most practical media for the field technician. The collected data should then be entered into a computer system for tracking. 

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