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Enterprise IT Solutions for Regulated Industries
We provide IT services built for pharma, biotech, and industrial companies where compliance is required.
Pharma IT Infrastructure
We set up and qualify IT systems for pharma environments — servers, networks, and disaster recovery — all following GxP rules.
- ✓Server IQ/OQ/PQ
- ✓Network validation
- ✓Disaster recovery
- ✓IT change control
21 CFR Part 11 Compliance
We review your systems, fix audit trail gaps, set up electronic signatures, and manage user access to meet FDA requirements.
- ✓Electronic signatures
- ✓Audit trail fix
- ✓User access management
- ✓Compliance gap review
Computer System Validation (CSV)
We handle the full CSV process — writing validation plans, running protocols, making traceability matrices, and preparing for inspections.
- ✓Validation Master Plan
- ✓IQ/OQ/PQ protocols
- ✓Traceability matrix (RTM)
- ✓Vendor audit support
Data Integrity & ALCOA+
We check your data systems using ALCOA+ rules and help you fix any problems before an FDA or EMA audit.
- ✓ALCOA+ review
- ✓Data governance
- ✓Audit trail check
- ✓FDA/EMA remediation
QMS & LIMS Integration
We connect your quality and lab systems with ERP, DMS, and manufacturing systems so everything works together.
- ✓QMS/LIMS/ERP connection
- ✓SOP digitization
- ✓eQMS setup
- ✓Change control system
Regulatory Submission IT
We set up the technology needed for regulatory submissions to FDA, EMA, and CDSCO — including eCTD publishing and RIMS.
- ✓eCTD publishing
- ✓RIMS setup
- ✓Submission data validation
- ✓CDSCO India support
Pharma Clients Served
Validation Projects Completed
Audit Pass Rate
Years in Regulated Industries
Ready to Strengthen Your Pharma IT Infrastructure?
Speak with our regulated-industry IT specialists about GxP-compliant infrastructure, 21 CFR Part 11, and CSV readiness.