Validated by Design, Ready for Inspection
MoniDoseQMS follows a risk-based validation approach aligned with GAMP 5 and FDA 21 CFR Part 11. We provide the documentation, protocols, and traceability — so you can achieve and maintain a validated state with confidence.
GAMP 5 Aligned Approach
Our validation methodology follows ISPE GAMP 5 principles, ensuring a structured, risk-based, and scalable approach to computer system validation.
Risk-Based Approach
Validation effort is scaled to the risk each component poses to patient safety, product quality, and data integrity. Higher-risk areas receive deeper testing, while lower-risk elements follow streamlined protocols.
GAMP 5 Category 4 Classification
MoniDoseQMS is classified as a configured product under GAMP 5 (ISPE 2nd Edition, 2022). This means the platform is validated as commercial off-the-shelf software with customer-specific configuration — reducing your validation burden.
V-Model Lifecycle
Our development and validation follow the V-Model approach: each specification level has a corresponding test level. User requirements map to performance qualification, functional specs to operational qualification, and design specs to installation qualification.
Validation Documentation Package
Every customer receives a comprehensive validation guide with protocol templates, traceability matrices, and execution guidance. You don't start from scratch — we provide the framework, you execute in your environment.
Three-Phase Qualification
A structured IQ/OQ/PQ approach ensures every layer of the system is verified — from installation to real-world performance.
Installation Qualification
Verifies that the system is correctly installed and configured in your environment. Covers infrastructure, database connectivity, authentication, file storage, and network configuration.
- Environment configuration verified
- Database connectivity confirmed
- Authentication services operational
- Encryption and security controls active
- Backup and recovery mechanisms in place
Operational Qualification
Confirms the system operates correctly across all intended functions and boundary conditions. Tests functional requirements, security controls, audit trail integrity, and electronic signature workflows.
- Functional requirements verified
- Security and access controls tested
- Audit trail completeness confirmed
- Electronic signatures validated
- Error handling and boundary conditions tested
Performance Qualification
Demonstrates the system performs reliably under real-world conditions with actual business processes. Includes end-to-end workflow testing, concurrent user scenarios, and user acceptance testing.
- End-to-end business processes verified
- Concurrent user performance confirmed
- User acceptance testing completed
- Disaster recovery procedures validated
- Performance under load verified
ALCOA+ Data Integrity
Every record in MoniDoseQMS satisfies ALCOA+ principles — the gold standard for data integrity in regulated environments.
Attributable
Every record is traceable to the person who created or modified it.
Legible
Records are readable, permanent, and retrievable throughout their retention period.
Contemporaneous
Data is recorded at the time the activity occurs, not after the fact.
Original
The first capture of information is preserved. True copies maintain full integrity.
Accurate
Records reflect what actually happened without editing, deletion, or overwriting.
Complete
No data is missing — all relevant information is captured and retained.
Consistent
Data follows the same format and logic across the entire lifecycle.
Enduring
Records are durable and available for the full required retention period.
Available
Data is accessible when needed for review, audit, or regulatory inspection.
Regulatory Frameworks
Our validation approach satisfies the requirements of major regulatory frameworks governing computerised systems in regulated industries.
FDA 21 CFR Part 11
CompliantElectronic records and electronic signatures meet all FDA requirements. Audit trails capture identity, timestamp, before/after values, and reason for change on every action.
EU GMP Annex 11
CompliantComputerised system controls satisfy European GMP requirements for data integrity, access control, audit trail, and change management throughout the system lifecycle.
GAMP 5 (ISPE 2nd Edition)
AlignedValidation approach is fully aligned with Good Automated Manufacturing Practice guidelines. Risk assessments, supplier qualification, and lifecycle documentation follow GAMP 5 principles.
ISO 13485:2016
CompliantThe platform supports organisations maintaining an ISO 13485-compliant quality management system for the design, development, production, and servicing of medical devices.
ICH Q9 / ISO 14971
AlignedRisk management methodology integrates with the validation lifecycle. System risks are assessed, mitigated, and monitored continuously — not just at initial deployment.
21 CFR Part 11 Compliance
MoniDoseQMS meets FDA requirements for electronic records and electronic signatures across every regulatory requirement area.
System Validation
Complete validation lifecycle with IQ/OQ/PQ protocols, traceability matrices, and ongoing periodic review.
Electronic Signatures
Two-component authentication (identity + password). Each signature captures signer identity, date/time, and meaning statement.
Audit Trails
Immutable, system-generated audit logs record who did what, when, and why — including before and after values for every change.
Accurate Copies
Export records in regulatory-ready formats with integrity verification. Exported copies faithfully represent the original electronic record.
Shared Responsibility Model
Validation is a shared effort. We provide the platform, documentation, and support — you own the execution and maintenance of the validated state in your environment.
MoniDose Provides
- Maintain a documented Software Development Lifecycle (SDLC)
- Provide validation documentation and protocol templates
- Perform regression testing with every release
- Publish release notes with change impact assessment
- Maintain vendor quality management system
- Support customer validation activities
You Own
- Develop validation protocols using our templates and guidance
- Execute and document IQ/OQ/PQ test cases in your environment
- Perform risk-based testing appropriate to your regulatory context
- Assess change impact when applying platform updates
- Conduct periodic reviews to maintain validated state
- Document deviations and corrective actions
Continuous Validation Readiness
Validation is not a one-time event. MoniDoseQMS supports continuous validation readiness through structured change management, impact assessment with every release, and annual periodic review guidance — so your validated state is maintained, not just achieved.
Ready to See Our Validation Package?
Request a copy of our Customer Validation Guide, including IQ/OQ/PQ protocol templates, traceability matrix examples, and risk assessment frameworks. No commitment required.