Healthcare IT Servicesfor Pharmaceutical & Biotech Companies
Streamline pharma and biotech operations with tailored IT solutions.
Our Healthcare IT services for pharmaceutical and biotech organizations enhance data management, workflows, and compliance.
Validated IT for Pharma & Biotech
Pharmaceutical and biotechnology companies require validated, GxP-compliant IT infrastructure that supports research, development, and manufacturing operations while maintaining regulatory compliance.
GxP Compliance
FDA 21 CFR Part 11 and EU GMP compliance
Validated Systems
Computer system validation and data integrity
Resilient Infrastructure
High availability and disaster recovery
Validation & Governance
Comprehensive validation and governance frameworks that ensure regulatory compliance and operational excellence.
Computer System Validation
Comprehensive CSV processes for all computerized systems
- Risk assessment
- Validation planning
- Testing protocols
- Documentation
Data Integrity
ALCOA+ principles implementation and monitoring
- Audit trails
- Electronic signatures
- Data backup
- Access controls
Change Control
Validated change management processes
- Impact assessment
- Testing requirements
- Approval workflows
- Documentation
Quality Management
QMS integration with IT systems and processes
- Quality planning
- Process monitoring
- CAPA management
- Training records
Regulatory Compliance
FDA, EMA, and other regulatory requirements
- 21 CFR Part 11
- EU GMP Annex 11
- Inspection readiness
- Compliance monitoring
Risk Management
ICH Q9 quality risk management principles
- Risk identification
- Risk assessment
- Risk mitigation
- Risk review
Products Applied for Pharma & Biotech
Validated healthcare technology solutions designed for pharmaceutical and biotechnology environments.
Validated Products
AISHA
Real-time transcription turning doctor-patient dialogue into notes.
SealsVault
AI-powered data lake with seamless management and audit controls.
Sealsforge
AI-powered MRP for precise inventory, production, and shipment.
OryxBlue
Free, easy-to-use HR management for up to 8 users.
Turbo Owl
Centralized document management with secure access and workflow control.
GxP IT Services
Infrastructure Management
Validated infrastructure with high availability and disaster recovery
Server Hardening
Security hardening with GxP compliance and validation
Backup/DR
Validated backup and disaster recovery solutions
Cloud Strategy
GxP-compliant cloud migration and hybrid architectures
Data Quality
Data integrity monitoring and ALCOA+ compliance
Regulatory Expertise
- • FDA 21 CFR Part 11 compliance
- • EU GMP Annex 11 requirements
- • Computer system validation (CSV)
- • Data integrity and ALCOA+ principles
Pharma & Biotech Outcomes
Proven results from pharmaceutical and biotechnology companies that trust Medisure with their validated IT systems.
Global Biotech Company
Challenge
Needed to validate and migrate critical manufacturing systems while maintaining GxP compliance
Solution
Implemented comprehensive CSV program with validated cloud infrastructure and data integrity controls
Results Achieved
Ready to Get Started?
Contact our team to learn how our Healthcare IT Services for Pharmaceutical & Biotech Companies can support your needs and improve your efficiency.
Call us now: +1 (951) 622-8126