Key 21 CFR Part 11 Compliance Features in Our Solutions
System Validation
Rigorous validation protocols ensure that all hardware and software components perform reliably and consistently, preserving data accuracy throughout the entire lifecycle.
Secure User Access Control
Role-based permissions restrict system access to authorized personnel only, preventing unauthorized data manipulation and ensuring accountability.
Audit Trails
Computer-generated, time-stamped audit trails document all electronic record changes, detailing who made the change, when, and why — enabling full transparency for regulatory audits.
Electronic Signatures
Our systems support FDA-compliant electronic signatures that uniquely identify and authenticate users, replacing traditional handwritten approvals without compromising security.
Data Integrity & Retention
All electronic records are securely created, stored, and archived with robust measures against loss, corruption, or tampering.
Comprehensive Training & Documentation
We provide thorough operational training and documentation to ensure your team meets compliance requirements and maintains ongoing system integrity.
