What I Build
Full-stack development services from frontend to backend, database to deployment.
Computer System Validation (CSV)
Full CSV lifecycle management from requirements through validation and ongoing maintenance.
FDA 21 CFR Part 11 Compliance
Electronic records and signatures that meet FDA requirements with complete audit trails.
HIPAA-Compliant Infrastructure
Healthcare systems built with proper access controls, encryption, and audit logging.
GAMP 5 Regulated Systems
Risk-based approach to validation following GAMP 5 guidelines for pharmaceutical systems.
Validation Documentation
IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
Audit-Ready Reporting
Systems designed to satisfy FDA, internal, and third-party auditors.
Technologies I Work With
What I Build For Clients
Real applications solving real business problems.
Bio-pharmaceutical Quality Systems
Validated systems for laboratory, manufacturing, and quality assurance in regulated environments.
Healthcare Compliance Infrastructure
HIPAA-compliant patient portals, provider systems, and claims processing with proper controls.
CSV Lifecycle Management
From validation planning through ongoing maintenance and periodic review.
Audit Preparation
Systems and documentation that satisfy FDA inspections and third-party audits.