Report documents system

Check whether a documented system is in place, which covers the reporting, investigation, root cause analysis and corrective actions taken. 

Of note, allied health care professionals soon may routinely assume a role as referring TeleStroke providers at spoke hospitals a recent case report documented the first delivery of rt-PA by an advance practice nurse in the ED at a hospital in rural Texas networked by a TeleStroke system to a stroke center in Houston. ... 

Testing must be conducted in a typical end-user environment, or in a simulated end-user environment, identical with the environment where the software/computer system will be used. Documentation of testing can be recorded as raw data, such as in a logbook, and should include the parameters tested, and the results of testing. The data should be tabulated as a final report document that includes all details included in the test plan, their execution, the results, and conclusions. The final report document must be signed by appropriate personnel, reviewed as needed, and archived. Upon successful completion of testing, the software/computer system can be released for testing and use in an actual end-user environment. 

A detailed and comprehensive system of record keeping is necessary, including, for example, worksheets, notebooks, computer output and reports, and all of these should be retained for a reasonable period of time or as required by the customer. A period of six years is often chosen. The content of reports and certificates is tightly defined, to ensure that customers receive all relevant information and that the laboratory does not make exaggerated claims about which parts of its work have been accredited. A documented system for dealing with any customer complaints and for informing customers if discrepancies in results are subsequently discovered must be available and in place. 

There is an effective documented system for receiving samples, identifying samples against requests for analysis, showing progress of analysis, issue of report and fate of sample. 

Reporting water analyses is most usually carried out using report pads. All service companies have various types of documents and multicopy report pads available, on which results can be tabulated. Many large customers also have their own specially printed report pads, and those that do not will create them from blank log books. There is little to choose between any of the document systems. The main requirements are to have the information written down and for that information to be readily available for inspection and interpretation. Today many organizations use SPC software programs, and information can be received directly from remote automatic... 

All levels of development testing for the computer system must be fully documented and provide test records in the form of approved test procedures, signed-off test result sheets, and reports. For system parameters, data, and functions that are critical to product quality and GMP compliance it is beneficial that the test procedures align with qualification test requirements, and record... 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

This observation is one of the most common received relative to OOS investigations and deviations. A comprehensive investigation may have been performed and a definitive cause found for the aberrant data, but there is no documented system in place to ensure that the corrective action committed to in the investigation report will be effected in its entirety and in the allotted time frame. 

Studies have also focused on vanadium-based asymmetric catalysts in addition to these photocatalytic systems. A catalytic achiral version of an oxidative coupling reaction was published in 1999 by Uang and co-workers (see Section 14.4.2) [70]. They developed an air-stable complex (VO(acac)2) that can be used in catalytic quantities in the presence of dioxygen as a re-oxidant. The promising results obtained led to an investigation of chiral versions of this reagent, and the initial reports document that such a reaction was possible with complexes... 

The research findings were disseminated to the interviewees, certain members of the European Commission, and the relevant European Parliament committee reporters. The systems framework was formatted and submitted as a short document to the RIP responsible for developing TGD for restriction and authorisation. Responses received were considered in terms of the overall contribution of the research project. 

In addition to specific documentation described above, laboratories must retain all schedules, logs, and reports of system backups, system failures, and recoveries or restores. 

A great deal has been written about manual documentation systems in the pharmacy literature, both in clinical practice and in education, but these systems tend to be individualized applications in which the transfer of data to other providers is nonexistent or quite limited. " Many documentation systems in pharmacy focus on the generation of reports for workload analysis or accreditation purposes. Unfortunately, the information gathered and analyzed in such... 

Documentation systems and applications must be easy to use, portable, produce useful reports, be replicated by others consistently, and allow for knowledge sharing with other providers. 

The GABA-receptor complex, the primary inhibitory neural network within the central nervous system, is associated with HE. This receptor complex is composed of a GABA-binding site, and a benzodiazepine receptor site, which mediate chloride conductance. Based on evidence of an increase in benzodiazepine receptor ligands in patients with hepatic encephalopathy, flumazenil has been evaluated in uncontrolled studies and has demonstrated significant clinical improvement, with one case report documenting long-term benefit. In these reports, discontinuation of flumazenil resulted in prompt clinical deterioration. 

Figure 5.12. A summary report for system suitability testing documenting result i.d., precision, and other system suitability parameters (S/N ratio, tailing factors, plate count, and resolution). Note that means and precision of each table column can be automatically calculated.

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