Case Study: Building a 21 CFR system for a global pharma database
Brief: The company, world leading in immunotherapy, contacted TotalLab to create a 21CFR ready solution for their 1D gel analysis, including data migration.
Deliverables: Accountability. Security. Reproducibility.
Client: Leading immunotherapy company
GxP Data Migration: We generated a seamless data transfer from the old system to the new, efficient 21CFR ready solution, allowing ready to retrieve data sets.
21 CFR Part 11 Compliance: The key implementations we built into the software help to aid compliance with 21CFR part 11. These are as follows: