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Tl’s seamlessly connected eClinical platform adheres to global regulations. Our platform architecture and capabilities helps life sciences organizations stay compliant and improve overall quality.
TI’s 21 CFR Part 11 compliant eClinical platform provides assurances for audit trail functionality, electronic signatures, security and data integrity, record retention, etc.
TI’s QMS complies with the ISO 9001:2015 international standard and is audited in accordance to enhance customer satisfaction.
All data centers comply with this standard for reporting on controls at service organizations.
Audited on rigorous quality standards for businesses – staffing, training, production, information management, and quality control measures.
TI’s policies and procedures are designed to comply with this standard and employees are required to pass introductory training.
Our computerized systems are GAMP 5 compliant and are evaluated based on the framework’s risk-based approach.
SSAE 16 SOC 2 Certified
24 x 7 Monitoring
Data Encrypted at Rest
Fully Redundant with Uptime SLA of 99.97%
BCP: RTO: 24 hrs.; RPO: 1 hr.
Monitoring: Nagios, Grafana, ELK, Zabbix and Pingdom
GxP, 21 CFR Part 11, Annex 11 Compliant
IaaS Configuration Logs (AWS Cloud Trail and Guard Duty)
IaaS Deployment Logs (AWS Cloud Formation)
Infrastructure Qualification / System Tests
Record Audit Logs
AWS Global Data Centers (N. Virginia, Oregon, Frankfurt, Dublin, Ningxia, Beijing)