Take advantage of PVLMC's decades of experience in successfully managing the process validation lifecycle and gaining regulatory approval of those biologics! This tool is designed to be used in MS Excel. It guides the user to track the required activities across the entire process validation lifecycle (from initial development to regulatory submission/approval and continued process verification). It is fully adaptable to allow product-specific activities to be added for any biologic product. The tool divides all process validation lifecycle activities into the FDA process validation stages 1, 2, and 3, and includes standard strategies and some additional alternative strategies from PVLMC best-practices.
 
Highlights of this tool include the following:
The tool is pre-loaded with 102 process validation activities across the different FDA stages. All typical activities required for eventual regulatory submission of your product are included. Additional activities for non-typical products may be added.
The tool is set up to track the activity, completion of activity outcomes, and the milestone dates for each.
The tool includes a mix of locked and unlocked entries to prevent deletion while allowing for process specific information to be added.  Pull down choices are also included for many entries to help reduce the time required for filling in the tool and to help maintain cohesion across the different users.  
A short tutorial on the use of the eTool is included.
This eTool is complimented by the Process Validation Lifecycle Management Strategies eTraining. Purchase of the eTool plus the eTraining includes a 50% reduction in the cost of a company eTraining license.