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:

Key Features:

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