Automatic auditing

However, many of these tools, while enabling markedly faster and more detailed analysis than paper-based methods, still mimic static, one-by-one paperlike reports with no real-time auditing capability. Moreover, these COTS do not have integrated data analysis and automated data screening capabilities and are not optimized for systematic analyses. Furthermore, the ad hoc analyses that these COTS produce lack interactive, automatic auditing reproducible functions. Thus these tools are often used to produce the same dense, unwieldy paper tables of counts and percentages that were created manually before personal computers became ubiquitous. 

The human factors audit was part of a hazard analysis which was used to recommend the degree of automation required in blowdown situations. The results of the human factors audit were mainly in terms of major errors which could affect blowdown success likelihood, and causal factors such as procedures, training, control room design, team communications, and aspects of hardware equipment. The major emphasis of the study was on improving the human interaction with the blowdown system, whether manual or automatic. Two specific platform scenarios were investigated. One was a significant gas release in the molecular sieve module (MSM) on a relatively new platform, and the other a release in the separator module (SM) on an older generation platform. 

Humans should use computers to do functional work for them in the most efficient manner possible. However, we must not delude ourselves into thinking that the mere use of a computer to analyze adverse events will magically analyze these events in a systematic, efficient way. Computers do not automatically produce coherent, auditable results that can be subsequently reproduced with ease. Computers must be actively programmed through an iterative process involving tight communication between analysts and software developers until these processes are totally functional. 

In electronic data packages used in held studies, there are some electronic data that are directly entered by the held investigator (FI) and some that are generated by the program (e.g., dates and times). Both types of raw data need to be verified by QA personnel, who should check not only directly entered data, but also computer-entered data. In order to conduct a thorough data audit, QA should determine which data are direct entry and which are automatic. 

For FieldNotes, the general log for the test substance will automatically track usage for each application at all sites. When the same container of test substance is used for several studies, the data will appear to be atypical. If QA is auditing individual study data, the numbers will not seem to be accurate for a particular study. QA must be made aware when one container is used for different studies during the audit. Consequently, sending a separate container of test substance for each trial and/or study is recommended in order to facilitate tracking during the audit. 

Is an electronic audit trail function automatically generated for all system administrator... 

There were no automatic computer generated time-stamped audit trails to ensure authen-tieity and integrity of analytical data that was acquired and processed with the CDS. Analyst s transactions were not documented to show whether the analytical data were modified, copied, or deleted. 

In many cases, initials on paper are used not because there is an explicit predicate rule requirement but to be able to trace, who performed certain activities. As an alternative, when changing from paper to an electronic system the audit trail or any other logfile can be used to automatically record who did what and when. The Table 8 outlines the differences. Table 9 illustrates the application of signatures and automatic logs in an example. 

A bias is added to the reactor conversion measurement with a magnitude of about 5 % of the current reactor conversion (sensor 2). Immediately after the bias change is introduced to the sensor, both the univariate chart for reactor conversion and the multivariate and SPE charts (Figure 8.7) indicate an abnormality. A CVSS model is developed to generate the residuals for sensor audit. The KBS automatically begins the sensor validation routine to determine the source cause of the inflated and SPE statistics. Figure 8.8 shows that the residuals mean for sensors 1 (initiator concentration), 2 (reactor conversion), and 4 (polydispersity) have exceeded... 

Authentication is usually performed by entering a unique user identification (ID) and password. If data are transferred automatically from external software, the source system either must provide a similar mechanism to identify a valid user or the external system has to log on to the record manager with a unique identifier. In any case, data that are entering a compliant-ready record manager require this identification. The authentication needs to be logged with a date and time stamp in an audit trail. The same requirement applies to the modification of data that already exist in the record, if the user is not already in an authenticated session. In fully regulated environments, a reason for the modification has to be supplied before changes can be made. 

Scientific data management requires a complete audit trail to be a part of the application, which must be electronic, always on, unchangeable, and able to work automatically without user intervention. The audit trail is linked to the record being changed and must be kept for the full record retention time. 

For regular tests a LIMS offers the functionality of automatic test programs that are used for processes, which can be planned exactly. Examples are calibration of instruments, audits, and assessment of environmental impact in regular intervals. After an automatic test program has been initiated, it starts working on a predefined relative date or time to compile and generate processes on the basis of the respective definitions in the standard. 

Auditability for safety considerations and to allow automatic recording of procedures, synthesis history and results. 

Each and every operation dealing with a file, be it a manipulation or evaluation, will automatically be documented and added as audit trail to the file in terms of the data block wTWffl. You have access to this history report by right-clicking on this icon. 

As discussed above, pharmacy data can provide insight into a patient s pattern of medication use and reveal compliance problems. Because many patients non-compliance takes the form of underuse of anti-inflammatory therapy and overuse of bronchodilators, a bronchodilator/prophylactic ratio which is inconsistent with the guidelines may indicate poor asthma control, and possibly poor compliance. Some clinics have an electronic automatic alert facility that alerts the clinician when this ratio becomes too imbalanced, and the ratio is also an important aspect of asthma audit. However, there are a number of reasons why the bronchodilator/prophylactic ratio should be treated with caution. 

Automatic Failure — A new entrant wdl automatically fail a safety audit and will receive notice that its USDOT new entrant registration will be revoked if formd in violation of any one of the following regulations ... 

The procedures to be used for a New Entrant Safety Audit have been updated in a new rule released by the Federal Motor Carrier Safety Administration (FMCSA) December 16, 2008. The new rule creates auto-fail violations, as well as using the normal acute and critical scoring used in all audit and compliance reviews. Anew entrant will automatically fail its safety audit if violations of any one of 16 essential FMCSA safety regulations are discovered during the 18-month safety monitoring period. 

A full audit trail of any changes to the hazard log was automatically maintained. This enabled many people to be permitted to contribute to the log without risk of losing information. 

Cease depehdehoe Oh inspection to achieve quality. Eliminate facility inspections to determine compliance to standards. Utilize demonstrated management commitment and audit the management system. If management is committed, safety compliance will be automatic. It is management s job to continually review the system. 

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