Security That Meets Regulatory Standards
Regulated industries demand more than standard cloud security. MoniDoseQMS is built from the ground up with encryption, access controls, and audit capabilities that satisfy the most rigorous compliance requirements.
Data Protection
Multiple layers of protection ensure your quality data remains secure, private, and available when you need it.
Encryption at Rest
All data is encrypted using AES-256, the same standard used by financial institutions and government agencies.
Encryption in Transit
TLS 1.3 secures every connection between your browser and our servers, preventing interception and tampering.
EU Data Residency
Your data stays in EU-based data centers. No transatlantic transfers, no adequacy decision dependencies.
Tenant Isolation
Each customer environment is fully isolated at the database and application layer. No shared tables, no cross-tenant access.
Automated Backups
Daily encrypted backups with 90-day retention. Point-in-time recovery available to restore data to any moment within the retention window.
Access Controls
Fine-grained access management ensures the right people have the right access — and nobody else.
Role-Based Access Control
Granular permissions tied to organizational roles. Users see only what they need, aligned to your quality management structure.
Multi-Factor Authentication
MFA enforced across all accounts. Supports authenticator apps and hardware security keys for strong identity verification.
Session Management
Configurable session timeouts, automatic lockout after failed attempts, and full session activity logging for audit purposes.
IP Allowlisting
Enterprise plan feature. Restrict platform access to approved IP ranges, ensuring only authorized networks can reach your environment.
Single Sign-On (SSO)
Enterprise plan feature. Integrate with your identity provider via SAML 2.0 or OpenID Connect for centralized authentication.
Certifications & Standards
Our security posture is validated through recognized certifications and compliance frameworks.
GDPR Compliant
CurrentWe process personal data in accordance with the EU General Data Protection Regulation. Data subject rights, lawful basis documentation, and DPO oversight are built into our operations.
EU Data Residency
CurrentAll customer data is stored and processed exclusively within European Union data centers. No data leaves the EU without explicit customer consent.
SOC 2 Type II
Planned 2026Independent audit of our security, availability, and confidentiality controls over an observation period. Validates that our controls work consistently, not just on paper.
ISO 27001
Planned 2027The international standard for information security management systems. Certification will formalize the security practices already embedded in our platform.
Compliance & Validation
Purpose-built for regulated environments where data integrity and traceability are not optional.
Computer System Validation (CSV)
MoniDoseQMS follows a risk-based CSV approach aligned with GAMP 5. We provide validation documentation packages including system requirements specifications, design specifications, and traceability matrices.
21 CFR Part 11 Compliance
Electronic records and electronic signatures meet FDA requirements. Complete audit trails capture who did what, when, and why. Electronic signatures include meaning, date/time, and are linked to their respective records.
ALCOA+ Data Integrity
Every record in MoniDoseQMS is Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available. Audit trails are immutable and system-generated.
IQ/OQ/PQ Documentation
Installation Qualification, Operational Qualification, and Performance Qualification protocol templates are available for all plans. Our team provides execution support to streamline your validation activities.
Incident Response
We maintain a documented incident response plan covering detection, containment, eradication, recovery, and post-incident review. Security events are classified by severity and communicated to affected customers within defined timeframes.
Data Processing Agreement
We provide a GDPR-compliant Data Processing Agreement (DPA) to every customer. The DPA details our obligations as a data processor, including sub-processor management, data transfer safeguards, and your rights regarding data access, portability, and deletion.
DPAs are executed as part of the onboarding process. If you need to review our standard DPA before engaging, contact us and we will provide a copy.
Request DPA