Samples and Results are the most commonly used LIMS modules, and enable automatic evaluation of results against Specification. The Specification can be numeric, e.g. ≥98.0% and ≤ 102.0%, or text: White Powder, Pass/Fail, Complies with the reference IR spectrum, etc. Samples in the module can be managed according to a configurable workflow like a QC workflow, ISO accreditation workflow, R&D, or others.
The deviation record shows the automatically assigned identification number and descriptive data like the deviation name, detection date, initiator, coordinator, deviation description, deviation classification, responsible person, root cause, CAPA action, customer notification, conclusion, and approval.
Methods: selection of the validation parameter to be evaluated
The drop down menu first lets you choose between full validation, exploratory validation, etc., then from the list of parameters to be validated, (Repeatability, Accuracy, Linearity, etc.). In the last step, you can choose from the list of algorithms that can be applied (Level by level from multiple measurements, or from parallel measurements).
Sample and Results detail
The sample detail shows descriptive data like the sample name, the batch number, receipt date, storage conditions, customer, etc. The Results table gives a list of parameters to be tested, corresponding units, required specification, the measured value and reported values, evaluation against the specification, the required and the calculated RSD, recorded by, checked by, and other configurable data fields.
An example of graphical evaluation of Linearity in the method validation module, showing the relationship between the concentration and the measured values. For a more detailed evaluation, a plot of residuals or supporting statistics can be used.
Graphical evaluation of repeatability
An example of the graphical evaluation of repeatability in the method validation module, showing the concentration levels (x-axis) plotted against the difference between the measurement and the average measured values at the given concentration level (y-axis). This graph shows the method variability/repeatability.
The desktop is a cross-road from which individual functional modules can be started, including Samples and Results, Controlled documents, Equipment, Reference Materials, Deviations, Changes, CAPA, Statistical data evaluation, etc. The desktop can be individually configured per user for maximum efficiency.