Biotech2024-11
Biotech: Clinical Data Pipeline with 21 CFR Part 11 Compliance
A clinical-stage biotech company needed a validated data pipeline for processing trial results before submitting to the FDA. Their existing pipeline was a mix of Python scripts and Excel files with no audit trail. We rebuilt it with full 21 CFR Part 11 compliance in 10 weeks.
Deploy time
Manual scripts, no audit trailValidated automated pipeline
FDA submission pipeline validated, audit-readyRead