Quality Control in Pharma Production
To release drug samples, producers have to fullfill severell steps in quality control. For this purpose, Kapelan offers a sophisticated system to document all steps. With the help of our FDA 21 CFR Part 11 compliance a gap-free traceability and proper archiving of your data is guaranteed.
The 21 CFR Part 11 compliant modules consist of 3 main segments:
- user accounting with role management
- document each step in Audit Trails
- secure data storage
The Part 11 compliant modules are part of the LabImage software and can be used for each app. Read more on the 21 CFR Part 11 Compliance as module in LabImage. LabImage delivers modules for device controling as well to create a closed system.