Paperless

What is less clear is how, or whether, the roles of pharmacists will grow or advance. Since no significant increase in the number of practicing pharmacists can be foreseen in the immediate future to take on this increasing workload, while hopefully continuing to expand services and the delivery of pharmaceutical care, pharmacy clearly faces a major challenge. More use of better trained, certified, or even licensed technicians is one approach. More automation and computerization is another. A rapid growth in the expected use of electronic prescriptions may also allow further efficiencies—even the prospect of a paperless automated process. 

Incorrect My second summer of interning, I was involved in the Company s conversion process as they began their shift towards "paperless audits". 

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 ... 

Six years ago, Public Key Infrastructure (PKI)—as any popular buzzword—seemed to be a remedy for (almost) every security problem and the electronic signature was supposed to be used by (almost) everyone very soon. Today, we are not much closer to the paperless world. Based on experience coming from a number of PKI projects, the author of this paper points out some obstacles preventing people from using the electronic signature and looks for solutions. 

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. 

Both CDER and CBER have indicated that they will stop accepting paper submissions in the near future, although the actual date for these mandates is not clearly defined. Under PDUFAII commitments, FDA agreed to develop a paperless electronic submission program for all applications by 2002. This means that companies planning submissions should develop standards and procedures to ensure that the electronic submission requirements can be met. 

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... 

To submit electronically a request for a meeting or teleconference, the sponsor should use the Request for a Meeting or Teleconference form provided by the CVM (Form FDA 34895 OMB No. 0910-0452). The sponsor should enter the data directly into an Adobe Acrobat form, attach the Agenda for the meeting, and submit the form to CVM as an Adobe portable document format (PDF) file (compatible with Adobe Acrobat 6.0).6 The electronic submission of a request for meeting or teleconference is part of the Center s ongoing initiative to provide a method for paperless submissions. 

Other environmental strategies include eliminating lead capsules by replacing them with a beeswax stopper. Fetzer s organic range of wines called Bonterra is packaged in recycled glass bottles, with labels made out of kenaf (paperless hemp), printed with soy-based ink. 

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. 

EDMSs are integral to the drive toward a paperless manufacturing environment. EDMSs also provide a useful tool to share information in a way that minimizes duplication and ensures that it is easily accessible when required. 

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... 

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... 

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. 

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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