Electronic record events

Demonstrate that audit trails are created and maintained for Date and time of operator entries and actions that create, modify, or delete electronic records (methods, sequences, raw data, results, reports, calibrations, standards, event logs)... 

Sometimes, even in this electronic age , paper is still the medium of choice. For retained records that must be made available to personnel responding to an emergency, paper is a better medium than electronic media, because paper can remain accessible during emergency events (e.g., power outages, fires, floods, etc.) that could render electronic records inaccessible. 

The recording of sequential photon pulses for measurements of low levels of electromagnetic radiation as well as the recording of emission decays. The pulses are recorded from electron emission events from some photosensitive layer in conjunction with a photomultiplier system. See also Time-Correlated Single Photon Counting Fluorescence... 

The point at which data becomes an electronic record should reflect its origin and intended purpose. For manufacturing and laboratory records this may be the initial point of data acquisition but for a clinical trail report it may be from the report s first official use. Electronic records can be divided into three categories based on their intended purposes instructions, events, and reviews. Using these categories, it is possible to determine when audit trails are applicable. Table 22-2 summarizes these concerns and needs. 

As a consequence of the distinctiveness of electronic records resulting from events, one area of awareness is amendment and (logical) deletion of these electronic records. Procedural controls must define the process of correction. The person supervising or checking the operation should perform amendments to event files. 

If any electronic record resulting from an event, instructions, information, or data that was part of a review is modified, the approver and reviewer must be prompted to repeat the review of the data. This repeat review must be prompted by procedural or technological controls. 

Adequate alternative arrangements need to be available in the event of a computer system breakdown to maintain access to electronic records for business continuity purposes. The time to bring the alternative arrangements into use should be related to the possible urgency to use them (e.g., access to electronic records to effect a recall must be available at short notice). 

In the event that there is an equipment alarm or process utility alarm, the computer system does not retain the alarm information as a permanent electronic record. [FDA... 

Electronic audit trail. Check if the audit trail records events as specified in the functional requirement specifications document. 

An important issue for regulatory authorities is the reconstruction of conclusions and reported results. Evidence of data integrity can often he based on the chronological sequence of events. The U.S. Food and Drug Administration (FDA) regulation 21 CFR 11, dealing with electronic records and electronic signatures, mentions in 11.10(e) one of the controls that must be used ... 

Technological Supplier ER/ES systems should be capable of recording all electronic record create, update and delete operations. Data to be recorded must include, as a minimum, time and date, unambiguous description of event and identity of operator. This record should be secure from subsequent unauthorized alteration. 

Comcidence experiments have been connnon in nuclear physics since the 1930s.The widely used coincidence circuit of Rossi [9] allowed experimenters to detennine, within tire resolution time of the electronics of the day, whether two events were coincident in time. The early circuits were capable of submicrosecond resolution, but lacked the flexibility of today s equipment. The most important distinction between modem comcidence methods and those of the earlier days is the availability of semiconductor memories that allow one to now record precisely the time relations between all particles detected in an experiment. We shall see the importance of tliis in the evaluation of the statistical uncertainty of the results. 

Referring to figure BLIP. 7 consider electrons from the event under study as well as from other events all arriving at the two detectors. The electrons from the event under study are correlated in time and result in a peak in the time spectrum centred approximately at the delay time. There is also a background level due to events that bear no fixed time relation to each other. If the average rate of tlie background events in each detector is R and i 2> then the rate that two such events will be recorded within time Ax is given by i g, where... 

With electronic devices subject to drift with time or handling, a record of the device used will enable you to identify suspect results in the event of the device being found to be outside the limits at the next calibration. A way of reducing the effect is to select devices that are several orders of magnitude more accurate than needed. (See later under Action on equipment found out of calibration.)... 

In postmarketing electronic longitudinal medical records, redundant and potentially contradictory information may come from several sources, (e.g., reports from medical residents, their supervisors, the attending physicians). In these cases time stamping of each event may help to delineate the important sequences in understanding the adverse events. 

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