Compliance & Quality
quiMSI is built from the ground up for regulated pharmaceutical manufacturing, ensuring your L2 integration meets stringent GxP requirements.
21 CFR Part 11 Compliant
Our platform adheres to FDA regulations for electronic records and signatures, providing:
- ✓Electronic signatures with full audit trail
- ✓Secure, timestamped records
- ✓User access controls and permissions
- ✓Data integrity and validation
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GxP Ready
Built for pharmaceutical manufacturing with 21 CFR Part 11 compliance and CSV support.
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Comprehensive Audit Trail
Complete traceability of all system actions, configuration changes, and data transfers.
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Data Security & Encryption
Encryption, secure communication channels, and role-based access control.
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Alarms & Exception Handling
Real-time or after-batch alarm propagation with included alarm count.
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Data Retention & Archival
Configurable retention policy with the middleware.
Computer System Validation (CSV)
quiMSI supports your validation efforts with comprehensive documentation packages:
- •Functional and Design Specifications
- •Installation and Operational Qualification (IQ/OQ) protocols
- •Traceability matrices
- •Risk assessments and mitigation strategies