Accelerate your product's development and commercialization by using our eTool! This eTool is designed to be used in MS Excel. This eTool outlines the entire CQA risk assessment process and pre-defines the potential CQAs. Scoring rules are included and an FMEA style assessment severity range is defined. The eTool can be adapted for a unique biologic if necessary (procedures for tool adaptations are included). The underline procedures used in this eTool were first derived from A-Mab: A Case Study in Bioprocess Development, CMC Biotech Working Group Web ISPE and/or CASSS, Ver 2.1, pp 001-278, Oct 30, 2009, and have been modified by the personal experiences of the PVLMC CEO.
 
Highlights of this tool include the following:
The A-Mab scoring process has been updated to include PVLMC best-practice approaches. These practices have been submitted to regulatory agencies multiple times, gaining regulatory approval.
The scoring rules and processes have been fully expanded to include scoring of high-risk process residuals.
It calculates the severity scores and auto assesses them against the defined severity limit to identify potential CQAs as final CQAs or non-CQAs. The mathematical equations within this tool are not validated so you will need to verify results when you document them in your report.
41 typical biologics-related potential CQAs have been pre-loaded into the eTool. Corresponding reference and acronym sections have also been included.
A short tutorial on the use of the eTool is included.
This eTool is complimented by the CQA Determination Strategies and Practices eTraining. Purchase of the eTool plus the eTraining includes a 50% reduction in the cost of a company eTraining license.