Data quality Reporting System

Historical DataBase Subsystem We have discussed the use of on-hne databases. An historical database is built similar to an on-line database. Unlike their on-line counterparts, the information stored in a historical database is not normally accessed directly by other subsystems for process control and monitoring. Periodic reports and longterm trends are generated based on the archived data. The reports are often used for long-term planning and system performance evaluations such as statistical process (quality) control. The trends may be used to detect process drifts or to compare process variations at different times. 

All surveyors need a database of technical information, which should include reports of accidents or of defects that could lead to accidents derived from other sources. He also needs a regular supply of technical documentation from his head office that keeps him abreast of technical developments. If his company operates an effective quality assurance system, they will periodically check that he is keeping these data properly and they may control the indexing of them. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

Although the providers of proficiency testing schemes should have a quality management system in place, on occasions problems can arise which will affect the quality of the data evaluation being carried out. These can include transcription errors during data entry, mistakes in the report, software problems and inappropriate criteria for evaluation being used. Such problems should be remedied by the provider once the problem has been identified. 

The choice of the reference reservoir for calculating 5 or e values is quite variable among different laboratories. Table 1 lists all the laboratories that have published Fe isotope data in an abstract or peer-reviewed journal as of September 2003, and include the form in which the data are reported (e.g., 5 Fe or 5 Fe), as well as the reservoir or standard used to define 5 or s values. A common procedure of all labs currently conducting Fe isotope studies is to measure at least three Fe isotopes, which is done to provide a check on data quality, primarily evaluation of potential isobaric interferences. The choice of reference reservoir used in this chapter follows the approach of other stable isotope systems such as oxygen, which defines... 

At the present time, several countries have well-organised and experienced spontaneous reporting systems which contribute the bulk of ADE reports. In particular the United States, the United Kingdom, France and the Scandinavian countries have records going back several decades, and can claim to have in their possession data of reasonable quality. The section on p. 438 considers the various methods of causality assessment that are available and the data that are required for their application. 

The assessment of project activities may include performance and systems audits, data quality audits, peer review, PE samples, as appropriate for a given project. Assessment enables project personnel to identify field and laboratory problems or variances from the project scope and to implement timely corrective action. The findings and response actions originating from assessment activities are documented in reports to management. 

Work performed in a laboratory must be traceable. This is achieved when all relevant information from sample preparation to experiments and reporting of data are recorded on paper or stored in a computer. In practice, this requires a quality management system of the laboratory. Continued effort toward good quality practice in the laboratory and, if possible, national accreditation of the laboratory (testing methods) is recommended. 

Document tracking CRF correction Data entry Data coding Quality control system Computer system, software Data reporting Record keeping Record retention Training initiatives... 

GxP data, records, and documentation including computer vahdation should be archived. Internal audit reports from self-inspections monitoring a pharmaceutical or healthcare company s compliance with its own quality management system do not have to be retained once corrective actions have been completed, so long as evidence of those corrective actions is kept (e.g., change control records). Supplier audit reports and periodic reviews are not internal audits and should be retained. 

The methods used for laboratory testing of held samples should have validated performance and be conducted within a rigorous quality management system. To avoid reliance on poor data, great care is needed to ensure that the test results reported are derived from methods of known performance that have been applied exactly. This can be confirmed by ensuring that full validation and quality control information is available to support test data.14... 

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