Continuous Compliance.
Uncompromising Data Integrity.
We transform Computer Software Validation (CSV) from a rigid annual bottleneck into a strategic state of continuous audit readiness for highly regulated laboratories.
Validation Engineered into the Architecture
In GxP, clinical, and ISO-regulated environments, software is only as powerful as its compliance framework. NRV Lab Informatics does not treat validation as an afterthought. We execute a rigorous, risk-based approach based on GAMP 5 methodologies, ensuring your LIMS, SDMS, and ERP middleware integrations meet strict global regulatory requirements from Day One.
Comprehensive CSV Services
End-to-End CSV Lifecycle (IQ/OQ/PQ)
Complete lifecycle management for new LIMS deployments, version upgrades, and system rescues.
- Validation Master Plan (VMP) creation
- Installation Qualification (IQ) & Operational Qualification (OQ)
- Performance Qualification (PQ) script execution
- Requirements Traceability Matrix (RTM)
21 CFR Part 11 & EU Annex 11
Rigorous engineering and auditing of your digital architecture to ensure strict adherence to electronic record mandates.
- Electronic Signature (e-Sign) workflows
- Immutable, system-generated audit trails
- Role-Based Access Control (RBAC) verification
- Biometric and SSO compliance integration
ALCOA+ Data Integrity Audits
Ensuring your laboratory data is flawlessly Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.
- Instrument interface validation
- LIMS-to-ERP payload data masking review
- Raw data retention & archival policies
- Identification of orphan or “ghost” data silos
Legacy System Remediation
Auditing out-of-compliance legacy laboratory systems and executing targeted remediation strategies to avoid FDA warning letters.
- System retirement and secure data migration
- Gap analysis and risk mitigation planning
- Retrospective validation of existing modules
- Quality Management System (QMS) alignment
Engineered For Global Standards
Is your digital architecture audit-ready?
Do not wait for an inspection to find gaps in your data integrity. Partner with NRV Lab Informatics to establish a permanent, proactive state of compliance.
Schedule a Compliance Audit