Familiarizing Laboratories with the LabVantage Pharma Package

After purchasing LabVantage’s Pharma package, an introduction to the pre-validated solution configured based on industry best practices is necessary. The course, lasting four days, will be taught just before the project begins.

The main aim is to make you feel confident with the program to allow for best use of your effort and time during the start of the project, the ensuing workshop, build testing, and end-user acceptance. Further information about this curriculum may be found in your project’s Statement of Work (SOW).

Target Audience

  1. Overview: What is LabVantage Pharma? What is provided in the package? Universal interface features. Navigation methods. How to use the help system.
  2. User Security: Security concepts of LabVantage. How to enable and configure departmental security for protecting data. Limiting access to modules and comprehending the role-based security module limiting user access to pages and functionality. Categorizing roles together utilizing job types and allocating job types to users.
  3. Parameters, Parameter Lists, and Test Methods: Develop experience in architecting your laboratory’s master data making it adhere to the types of tests you conduct on your samples.
  4. Specifications: Establish your quality control pass/fail limits to have LabVantage flag the test results when they fail to meet your criteria. Connect those limits to a Product to set the tests and specification limits depending on the manufactured product.
  5. Sample Login: The initial step in a sample’s lifecycle. Discover the various options and benefits. The next step in a sample’s lifecycle records the physical receipt in the laboratory.
  6. Sample Data Entry: The third step is to conduct a test and track the results.
  7. Sample Completion: Once the tests are finished, allocate a disposition to the sample.
  8. Instruments and Analysts: Distinguish the instruments that your laboratory utilizes, along with the calibration and maintenance intervals to ensure preventative maintenance and calibration are carried out at the necessary intervals. Utilize work orders to show instrument suitability.
  9. Manufacturing Quality Batches: Set up Sampling Plans for product manufacturing to pre-define sampling and testing specifications for quality control of batches and samples.
  10. Analytical Quality Control Test Batching: Make a worklist enumerating every sample that requires a particular test to be conducted on them. Order the list, assign it to an analyst, and employ it to help prove system suitability if necessary.
  11. Consumables Management: Keep a record of your inventory, link a reagent lot to a test that was conducted on a sample or testing batch, and utilize the concentration of a solution to determine the value of a test result.
  12. Stability Study Management: Assess the performance of a product that is stored under various environmental conditions to establish shelf life or show its safety and effectiveness over time.
  13. Environmental Monitoring: Organize a calendar for the routine collection of samples from various sample points. Utilize this to conduct environmental monitoring or to establish work orders for recurring maintenance.

Typical Daily Agenda

Day One Day Two Day Three Day Four
Overview Materials Instruments and Training Records Stability
Navigation Products QM Batching Scheduler
Security, Users, and Roles Sample Login AQC Batching Capstone
Tests Sample Receipt and Data Entry Reagents  
Specifications Sample Completion    

 

About LabVantage Solutions

LabVantage Solutions, Inc. is the leading global laboratory informatics provider. Our industry-leading LIMS and ELN solution and world-class services are the result of 35+ years of experience in laboratory informatics. LabVantage offers a comprehensive portfolio of products and services that enable companies to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate recordkeeping and comply with regulatory requirements.

LabVantage is a highly configurable, web-based LIMS/ELN that powers hundreds of laboratories globally, large and small. Built on a platform that is widely recognized as the best in the industry, LabVantage can support hundreds of concurrent users as well as interface with instruments and other enterprise systems. It is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and bio banking. LabVantage domain experts advise customers on best practices and maximize their ROIs by optimizing LIMS implementation with a rapid and successful deployment.


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Last updated: Aug 15, 2019 at 8:49 AM

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