Typical paper-based Quality Testing systems are not only inefficient and extend process times; they are also the one overarching cause of high compliance risk. The inherently error-prone, paper-based Quality Testing systems deployed at many Pharmaceutical and Biological manufacturing sites can become serious issues during FDA Quality Testing inspections. FDA-issued 483 warning letters are only the beginning of a significant remediation and "corrective and preventive action" (CAPA) process that takes additional time and money away from what the Quality Testing system should be focused on the release of product.
This webinar will discuss these challenges and illustrate a typical workflow with the BIOVIA Quality Testing solution that helps to overcome these challenges.
Quality Testing activities often begin in an Enterprise Resource Planning (ERP) system where an inspection lot is created, released and submitted. This information can be automatically transferred into the BIOVIA Quality Testing solution which connects directly to the ERP system. In cases where an ERP system is not in use, a Laboratory Information Management System (LIMS) is typically deployed and creates the inspection lot for submittal to the BIOVIA Quality Testing solution. Once the samples are submitted, the BIOVIA Quality Testing solution then assigns the requisite tests to be administered against the samples and verifies that all of the required inventory items are available in the quantities needed. Therefore, once the testing starts, the analysts do not have to stop their work and order more inventory items, or worse, wait for an inventory item to be shipped from the manufacturer. The analyst is executing the procedure "as it is written," thereby avoiding one of the key findings of FDA 483 warning letters by eliminating the potential introduction of incorrect data. This alone has a dramatic impact on the overall quality and accuracy of the test procedure.
Watch this webinar to learn how the BIOVIA Quality Testing solution increases productivity and efficiency, reduces costs and improves regulatory compliance. Ultimately, the solution helps pharmaceutical manufacturing teams make better decisions faster, reduce cycle times and accelerate product releases without increasing compliance risks.
Sr. Director, Products and Marketing for the Laboratory Informatics Portfolio
In this role Gene is providing the vision, strategy and management of the laboratory informatics product portfolio that includes the Electronic Laboratory Notebook, Laboratory Information Management System and the Laboratory Execution system. Gene has been working in the Life Science industry for over 20 years developing robotic and Laboratory informatics systems.
Dr. Daniela Jansen,
Product Marketing Manager
Dr. Daniela Jansen is Product Marketing Manager at BIOVIA and has more than 20 years of experience in laboratory informatics and instrumentation holding various positions in Marketing and Sales Management. She is working on the strategic product positioning and customer benefits of the BIOVIA Life Science solutions and has expertise in 21 CFR Part 11 Compliance and Lean Six Sigma.
- Why quality testing processes don’t need to be a bottleneck in your laboratory.
- How Quality Testing from BIOVIA can reduce compliance risk in your organization.
- What are the benefits of transitioning from a paper-based to an electronic Quality Testing solution?
- What is the impact of eliminating paper from your Quality Testing processes for your bottom line?
- Chief Operating Officer
- VP/Director/Manager of IT
- Quality Engineer
- VP/Director/Manager of Manufacturing
- VP/Director/Manager of Quality
- VP/Director/Manager of Operations
- Lab Manager
- Lab Analyst
- VP/Director/Manager Regulatory