300 – LabVantage Pharma Familiarization
If you have purchased LabVantage’s Pharma package, you will need an introduction to the software, the Pharma program, and the overall LIMS best practices. This four-day course will be delivered just before the project kick-off. The goal is to get you familiar with the program to streamline the use of time and efforts during project kickoff, the ensuing workshop, build testing, and end-user acceptance. Additional information about this curriculum may be found in your project’s Statement of Work (SOW).
System Owner, Project Manager, Subject Matter Experts (SME) and laboratory user personnel who will be helping to make decisions about and roll out your implementation. The daily schedule can be adjusted as necessary to deliver role-target education to different audiences.
- Overview: What is LabVantage Pharma? What is delivered in the package? Universal interface features. Navigation techniques. Using the help system.
- User Security: Security concepts of LabVantage. How to enable and configure departmental security for shielding data. Restricting access to modules, understanding the role based security module restricting the user access to pages and functionality. Grouping roles together using jobtypes and assigning jobtypes to users.
- Parameters, Parameter Lists, and Test Methods: Gain experience in architecting your laboratory’s master data making it conform to the types of tests you perform on your samples.
- Specifications: Establish your quality control pass/fail limits to have LabVantage flag the test results when they do not meet your criteria. Link those limits to a Product to set the tests and specification limits depending on the product being manufactured.
- Sample Login: The first step in a sample’s lifecycle. Learn the different options and advantages. The second step in a sample’s lifecycle records the physical receipt in the lab.
- Sample Data Entry: The third step is to perform a test and record the results.
- Sample Completion: Now that tests are complete, assign a disposition to the sample.
- Instruments and Analysts: Identify the instruments that your laboratory uses as well as the calibration and maintenance intervals to make sure preventative maintenance and calibration are performed at the required intervals. Use work orders to demonstrate instrument suitability.
- Quality Management (QM) Batching:Set up Sampling Plans for manufacturing of products to pre-define sampling and testing requirements for quality control of batches and samples.
- Analytical Quality Control (AQC) Batching: Create a worklist enumerating all the samples that require a certain test to be run on them. Order the list, assign it to an analyst, and use it to help prove system suitability if needed.
- Reagents and Standards Management (RSM): Keep track of your inventory, link a reagent lot to a test that was performed on a sample or AQC batch, and use the concentration of a solution to calculate the value of a test result.
- Stability: Evaluate the performance of a product that is stored under different environmental conditions to determine shelf life or demonstrate safety and effectiveness over time.
- Scheduler: Set up a calendar for routine collection of samples from different sample points. Use this to perform environmental monitoring or to create work orders for recurring maintenance.
Typical daily agenda
|Day One||Day Two||Day Three||Day Four|
|Overview||Materials||Instruments and Training Records||Stability|
|Security, Users and Roles||Sample Login||AQC Baatching||Capstone|
|Tests||Sample Receipt and Data Entry||Reagents|