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6.10 <br />Data approval shall be configurable by the user to require <br />a second person to approve the data other than the <br />person who entered the data. <br /> <br />6.11 LIMS shall provide for tracking of approval status. <br />6.12 <br />LIMS normally shall only report approved data. Reporting <br />of unapproved process control data may be configured by <br />authorized users. <br /> <br />6.13 <br />LIMS shall only allow modification of approved data by <br />authorized users and shall provide notification to specified <br />users whenever approved data is changed. <br /> <br /> <br />7. Quality Assurance / Quality Control (QA/QC) <br /> <br />ID # Description <br />Vendor <br />Response <br />(see Index) <br />Comment <br />7.1 <br />Application shall provide functionality compliant with the <br />requirements of the 2016 TNI Standard for Environmental <br />Laboratories V1M2 Section 5.9 “Quality Assurance for <br />Environmental Testing.” <br /> <br />7.2 LIMS shall be set-up to round data to user specified <br />number of significant figures using EPA rounding rules. <br />7.3 <br />LIMS shall allow all QC samples including replicates and <br />spikes with a specific batch to be automatically <br />scheduled. <br /> <br />7.4 <br />LIMS shall be set up for producing fully automated, on- <br />demand control charts for each method, including <br />charting blanks, spike recovery, spike-duplicate recovery, <br />relative percent difference between duplicates, control <br />standard recovery, and certified reference samples. <br /> <br /> 7.5 <br />LIMS shall keep an audit trail of any changes made to the <br />data as well as changes made to the approval status of <br />tests. <br /> <br />7.6 LIMS shall allow user to define quality control <br />specifications for each method and/or sample. <br />7.7 <br />LIMS shall be able to relate all batch QA/QC information <br />to sample test results, instrument, project, analyst, and <br />date. <br /> <br /> <br />8. Data Transfer <br />2304