Life Sciences Quality Management Software

Yes, quality tasks can be traced in the system, including lab analysis, inspections, and documents verifications. Tests/controls to be executed can be defined based on the material and its purpose (e.g., commercial use or R&D). Results can be recorded in the system and used to run a final quality assessment. 

Yes, it can define when reduced testing is allowed based on the material and vendor qualification status, as well as the frequency of mandatory full testing (defined by days or by the number of batches received). When reduced testing is applicable, non-mandatory tests can be skipped. 

You can manage sample inventory in the system (receipt, storage, shipping, destruction). Define rules to automatically calculate sample container count, quantity, unit, and types required. The solution integrates with the Weighing and Dispensing module, allowing sample preparation by connecting the ERP with scales. 

The solution allows you to plan recurrent quality controls for environmental monitoring. It also helps you define the recurrence period and controls to be executed. You can plan quality controls to support stability studies testing as well.

You can assign/change batch quality status. Based on the status, the batch will be available or blocked for consumption, transfer, shipping, etc. Controls to manage batch status include: 

- Changing batch status, which is allowed only for users with proper permission 

- Blocking the release of a batch with unreleased components 

- Blocking the release of a batch without a manufacturing date