Paperless system

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... 

Safeguards should be instituted to prevent the nnintended use of unapproved, superseded, or withdrawn documents. Many firms nse andits for this purpose. Management must ensure that persormel do not retain nnanthorized copies of docnments (e.g., photocopies), as these could not be relied upon after they have been revised. Where paperless systems distribute copies of documents, these should be clearly marked as having a limited shelf life. Beyond this date they lose all validity whether or not they have been superseded. A shelf life of one week is often recommended. 

The introduction of paperless systems has meant that specific consideration has to be given to the way that ERES are created and subsequently managed. The method and justification for preserving data on electronic media should be documented in sufficient detail and communicated to all relevant... 

Given these goals and objectives for paperless systems, it is perhaps helpful to look at the specific business and functional requirements that drive and enable them. 

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. 

However, the consequences on the technical side of the transition to paperless operations should not be underestimated. Paperless systems are normally much more complicated to operate and maintain from the technical side than traditional equipment. Thus, an operation must expect to have more staffing of competent technical people to support the operation and maintenance of the systems and to have clearly defined maintenance agreements with their suppliers. 

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. 

In addition to the life cycle stages, supporting activities for a document must be defined, i.e., what can happen to a document at all stages of its life cycle, for example, storage, retrieval, backup, format changes and so on. This may not be inherent in a paper-based system but may need to be specified when implementing a paperless system. 

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. 

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. 

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. 

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. 

Advances in information technology are now impacting upon the pharmaceutical industry. Many documents are now maintained in electronic format. In fact, some regard it as likely that in the future paperless facilities will become commonplace, with all documentation being computerized. Several aspects of such electronic document maintenance deserve special attention. Adequate back-up files should always be retained. Also, restricted access to computerized systems is required to ensure that data/documentation is only entered/amended by persons authorized to do so. 

A local physician has approached you about the possibility of establishing a paperless e-prescribing system with your pharmacy. What are the risks involved, and how can you minimize those risks ... 

E-mail is probably the most widespread ready-made application where electronic signature can be used and is used. Work flow and document management applications are other examples of information systems where an electronic signature is needed. Those applications are mainly dedicated to closed communities of users and documents with a limited validity period. The paperless office is the type of application that may be most promising for coming years. 

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. 

Initially, the implementation of a paperless documentation system in an enterprise is driven by a need or... 

The true business value of an EDMS is realized to the extent that it serves as more than just the terminus for document-related activities in an enterprise. To fully realize its goals, an enterprise paperless documentation system will perform functions across the entire document life-cycle. In addition to the storage of existing documents, users with appropriate system privileges must be able to create new electronic documents from within the electronic document management system. The system must explicitly support the file formats used by the business, which typically include word processing, spreadsheet, graphics, and database files. 

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