Who We Are
Simvic IT is a Rhode Island-based IT consulting and compliance firm focused on enabling digital excellence in regulated environments.
We bring together a team of experts with over 15 years of hands-on experience supporting GxP-regulated systems, IT infrastructure, and R&D digital transformation initiatives in top Biopharma and Biotech companies.
Who We Are
Who We Are
Who We Are
Simvic IT is a Rhode Island-based IT consulting and compliance firm focused on enabling digital excellence in regulated environments.
We bring together a team of experts with over 15 years of hands-on experience supporting GxP-regulated systems, IT infrastructure, and R&D digital transformation initiatives in top Biopharma and Biotech companies. .
Our Mission
Who We Are
Who We Are
To empower Life Science organizations with secure, validated, and business-aligned IT ecosystems that meet the highest standards of quality, data integrity, and regulatory compliance.
Our Values
Who We Are
Our Values
- Integrity: Every solution we deliver is built on trust and transparency.
- Compliance: We help you stay audit-ready, every day.
- Innovation: We enable digital agility through modern, risk-based approaches.
- Collaboration: We partner with your teams to deliver lasting impact.
Our Services
Network Design and Implementation
Network Design and Implementation
Network Design and Implementation
Our network design and implementation services help you build a scalable and reliable network infrastructure. We offer a range of services, including network architecture design, installation, and configuration to help you achieve your business objectives.
Cloud Migration and Management
Network Design and Implementation
Network Design and Implementation
Our cloud migration and management services help you move your business to the cloud with confidence. We offer a range of services, including cloud migration planning, implementation, and ongoing management to help you get the most from your cloud investment.
IT Project Management
Network Design and Implementation
Our IT project management services help you plan, execute, and deliver successful IT projects on time and within budget. We offer a range of services, including project planning, risk management, and vendor management to help you achieve your goals.
Cybersecurity & GxP IT Risk Management
Protect your systems, data, and users across regulated IT environments:
- Cybersecurity frameworks: NIST CSF, CIS Controls, ISO 27001
- Data Privacy (GDPR, HIPAA) Compliance
- IT Risk & Vulnerability Assessments
- Access Controls and Identity Management
- Incident Response and Business Continuity Planning
IT Operations & Managed Services
Computer System Validation (CSV) & Computer Software Assurance (CSA)
Reliable IT operations designed for regulatory compliance and scalability:
- IT Infrastructure Monitoring & Maintenance
- Disaster Recovery and Backup Strategy
- Incident & Change Management aligned with ITIL
- Vendor Management and SLA Oversight
- End-User Support and Service Optimization
Computer System Validation (CSV) & Computer Software Assurance (CSA)
Computer System Validation (CSV) & Computer Software Assurance (CSA)
Ensure your systems meet regulatory expectations with risk-based, audit-ready validation services:
- Validation Master Plans (VMP) and Validation Strategies
- URS, FRS, DS, IQ/OQ/PQ, and Traceability Matrix Development
- SaaS and Cloud System Qualification
- Data Integrity Assessments and 21 CFR Part 11 Compliance
- Periodic Review, Change Control, and Re-Validation Support
IT Strategic Planning & Governance
IT Strategic Planning & Governance
IT Strategic Planning & Governance
Align technology with business and compliance goals:
- IT Roadmaps and Digital Strategy
- Governance, Risk, and Compliance (GRC) Frameworks
- Budgeting and Cost Optimization
- Vendor Evaluation and Performance Tracking
- IT Audit and Inspection Readiness