01
Uncompromising Regulatory Compliance
Built for Global Standards: EMA GVP Module II; US FDA 21 CFR Part 11; GAMP 5; EU GMP Annex 11
Trust and Security at the Core of Your Operations
In the highly regulated landscape of pharmacovigilance, data integrity and security are not just features; they are the foundation. PSMF Manager is engineered from the ground up to meet the strictest global compliance standards, ensuring your data remains secure, traceable, and always audit-ready. Your compliance operations never sleep, and neither does our infrastructure.
02
Continuous Audit Readiness
Comprehensive Audit Trails, QMS Integration, Version Control
03
Robust Data Protection & Architecture
End-to-End Encryption; Single Source of Truth; Role Based Access Control
04
Business Reliability & Uptime
High Availability; Automated Backups; 24/7 security monitoring; vulnerability assessments
Certifications
Validated and Compliance-Ready by Design
Aligned to globally recognized expectations for quality, traceability, and regulated electronic records.
Enterprise-Grade Security Controls
Layered safeguards to keep confidential pharmacovigilance data protected, available and audit-traceable
Authentication
Password control, QC check, 2FA and Granular Access Controls to enhance security & accuracy
Encryption
SSL/TTLS protocols ensure secure encrypted transmission and safe storage of all data
Backup
Continuous protection of data automatically on AWS Cloud to prevent any loss of data
Audit Trails
Audit trails with detailed logs of actions, ensuring accountability and compliance
Want a closer look at our compliance framework?
See exactly how we map workflows to secure, audit-ready controls.
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