Compliance
The core of our being
Regulations. By Design.
Encapsia is designed on a basis of industry leading expertise and knowledge of world-wide regulatory requirements relating to the use of eClinical, eSource and cloud-based clinical data systems.
This expertise is the foundation of each encapsia component and is woven throughout the software development lifecycle to ensure key regulations including Food and Drugs Administration 21 (FDA 21), Code of Federal Regulation 11 (CFR 11), Good Clinical Practice (GCP) E6(R2), General Data Protection Regulation (GDPR), Health Insurance Portability and Accountability Act (HIPAA) and Data Integrity are fully and demonstrably supported.