21 cfr part 11 fda compliant concerning pre-clinical drug safety | |||||||||
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Using the clinical laboratory software known as ClinAxys II the status of outstanding work for each department - biochemistry, haematology or urinalysis for instance - can be displayed at any time. For each test requested, the system knows whether it has been entered, worklisted, or if a result has been entered or reported. Data consistency checks are applied during sample reception and any problems can be sent to a 'Helpdesk' printer for action. A final report cannot be printed until all inconsistencies have been resolved. The 'Helpdesk' will also be informed if any analytical results exceed a defined study-related range. These alert messages are designed to prompt further action, for example a phone call to the investigator. Dual entry of subject demographics is a client-definable parameter that allows for checking of originally entered data. Dual entry of manual results is also client-definable with the ability to prevent the same operator performing the second manual results entry on the same test. The audit trial is a vital requirement for all clinical laboratory software, especially in a multi-disciplinary environment. Where reporting is required in many different formats, the system permits data to be transmitted directly to the sponsor in a user-defined Electronic Data Interchange format (i.e. edi software). The reports design facility enables the user to produce both individual and cumulative clinical reports to the sponsors' numerous formats. Cost-reporting and workload statistics, can be accumulated over time so that monthly and annual totals of work completed can be reported. | ||||||||
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