Human cells, tissues, and cellular products (US)
Manufacture biologics & stand up clinical labs work confidently
Take complex biotech processes in-house with easy compliance oversight
21 CFR 1271
AATB
Tissue banking standards
ISO 15189:2022
Quality in medical laboratories
ISO/IEC 17025:2017
Testing and calibration lab competence
How it works
Activate frameworks
Out-of-the-box compliance with 15189, 21 CFR 1271 & more.
Get audit-ready 80% faster
Automate SOP mapping & objective evidence collection.
Monitor compliance
Risk analysis updates in real-time as you update policies & suppliers.