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| July 2007 | ||||||||||||||||
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In this issue...
Getting More Out of your LIMS, Part 1 - Worklist Management Nexxis ELN Automates and Controls an SOP for Tablet Content Uniformity
Labtronics Announces New COO |
Nexxis ELN Automates and Controls an SOP for Tablet Content Uniformity
This article will show how Nexxis ELN can control and monitor the execution of a Standard Operating Procedure (SOP) for determining Tablet Content Uniformity in a regulated environment, ensuring that all of the requirements of the SOP are being satisfied every time. We will see how a Nexxis ELN worksheet can ensure that: • The balance being used meets the requirements of the test • The balance has been successfully calibrated • The analyst has followed all steps defined in the SOP • All data has been collected electronically eliminating the possibility of transcription errors • All calculations are carried out by Nexxis ELN ensuring consistency and accuracy • The results are checked to ensure that they are within acceptable limits The Nexxis ELN worksheet that we will be describing is one that we have created as an example of how a laboratory might do a test for content uniformity. Don’t worry if your procedure is different. Nexxis ELN worksheets are completely configurable and are typically based on the paper worksheets or SOP that a laboratory is currently using. Before we walk through the steps in the worksheet, let’s take a quick look at some Nexxis ELN concepts.
Nexxis ELN is a web-based application that transforms manual paper-based procedures (worksheets, forms, SOPs, QC Sheets, etc.) into automated electronic worksheets, enhancing the overall management, documentation and control of analytical procedures. System Architecture Nexxis ELN uses an electronic worksheet approach that combines instrument interfacing, with user definable interactive procedures, automation of SOP’s and the ability to communicate with databases and database applications. The Nexxis ELN web client manages the user interface through Microsoft® Internet Explorer®, eliminating the need to install software on the client side. This simplifies deployment of Nexxis ELN and reduces the time and effort required to validate the solution in a regulated environment.  Figure 1: Nexxis ELN System Architecture The application logic and data management for Nexxis ELN are handled by the central Nexxis Administrator and Server. Nexxis ELN uses the existing network infrastructure to connect laboratory instruments to a central server via either a direct connection or a serial to TCP/IP converter. All communications with the instrument, including sending commands and collecting data, are carried out directly between the instrument and the server. Any client can be linked via the server to any instrument that is connected to the network. All data collected from the instruments resides on the server, the data never resides on the client. Nexxis ELN Methods A Nexxis ELN method is essentially an electronic version of a worksheet or an SOP that defines, controls and documents all aspects of the analytical process. Nexxis ELN methods can control which analysts are able to perform specific tests, determine which instrumentation is used for the analysis and even confirm that the instrumentation has been properly calibrated according to laboratory procedures. Nexxis ELN methods are interactive, guiding the analyst through each step of the analysis - collecting data from the instrument(s) that are being used and accepting input from the analyst when necessary. The Nexxis ELN electronic worksheet also performs all calculations associated with the analysis, stores result data and generates reports.
Our Nexxis ELN worksheet for Tablet Content Uniformity starts by giving the analyst a drop down list of products to select from for this test. The analyst then selects a LIMS ID from another drop down box that has been updated to only show values from the LIMS that match with the product selected in the first step. Using dynamic, drop down lists means that analysts don’t need to write down or type in product details. Upon selecting a LIMS ID, the Target Weight and Target RSD associated with the product type are automatically retrieved from LIMS, eliminating the need for the analyst to look these items up and manually record them in the worksheet. With that information in place, the worksheet then presents the analyst with a pre-defined list of balances that are suitable for the test and the type of product that they are testing. Nexxis ELN then automatically checks a calibration database to see if the balance has been successfully calibrated according to schedule. Nexxis ELN can integrate with your existing calibration database or you may want to consider Nexxis CAL, Labtronics’ Calibration Management application.  Figure 2: Nexxis ELN worksheets are completely configurable and are typically based on the paper worksheets or SOP that a laboratory is currently using. If the calibration for that balance is not up to date, then Nexxis ELN will ask the analyst to branch to a calibration routine before continuing with the analysis. This is a good place to point out that Nexxis ELN can control access to each step of a worksheet, making sure that each step is completed in order and that all of the SOP requirements have been fulfilled before moving to the next step.
The Nexxis ELN calibration worksheet walks the analyst through the process of calibrating their balance. Nexxis ELN can automatically fill in information, like the Balance ID from the previous worksheet and the date, so that all the analyst has to do is execute the calibration procedure. A “Get Weight” button is used to automatically collect the calibration weights from the balance. With a single click Nexxis ELN can monitor the balance until stability is achieved, record the calibration weight to a database, displays it on the client screen, compare the result against defined limits and assign a pass or fail result to the balance. Once the calibration has been successfully completed, Nexxis ELN automatically records the results in the calibration database, updates the calibration status of the balance and returns the analyst to the Tablet Content Uniformity worksheet to proceed with the tablet weighing.
After Nexxis ELN has automatically collected and recorded a stable weight for each of the tablets, it automatically calculates and displays the Average Weight, Standard Deviation, Minimum Weight and Maximum Weight. The worksheet also automatically queries a limit table that includes acceptable ranges for this product. Nexxis ELN determines whether the results are in range or not and displays that on the Nexxis ELN client screen, for the analyst. An electronic signature and date and time stamp are applied to complete the worksheet.
You can run our Nexxis ELN sample worksheet for Tablet Content Uniformity right from your desktop by visiting Nexxis LIVE. To find out more about Nexxis ELN, visit the Nexxis ELN product page on our web site or contact us to discuss how you can use Nexxis ELN to automate, control and document your paper-based procedures. |
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