The BIOVIA Quality Testing Solution

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.