Our Services
Comprehensive CSV Consulting & Solutions
End-to-end validation, infrastructure management, data integrity, and auditing services for regulated industries.
Practice Area · CSV
Computer System Validation
Comprehensive CSV processes to help organizations ensure regulatory compliance and system reliability.
CSV Planning & Strategy
Regulatory compliance requirements like FDA 21 CFR PART 11, EU ANNEX 11, GxP (GMP, GLP, GCP), ICH Q7/Q9/Q10
Validation Life Cycle and Documentation
Complete validation lifecycle and comprehensive documentation management
Validation Testing and Execution
Comprehensive testing protocols and execution
Post Implementation Support
Ongoing support after system deployment
Computer Software Assurance
Software assurance and quality management
What Computer System Validation Services Cover
CSV services help organizations validate systems such as:
Manufacturing process equipment computerized systems
Laboratory equipment computerized systems
Engineering equipment computerized systems
IT infrastructure qualification
ERP systems (SAP)
Quality management systems (QMS)
Spreadsheets and custom applications
Clinical trial systems
Medical device software and others
Practice Area · IT Infrastructure
IT Infrastructure Management Solutions
Complete infrastructure solutions to keep your IT environment secure, scalable, and efficient.
Hardware & Software
IT infrastructure hardware and software management
Network Integration & Security
Network integration and security solutions
Access & Surveillance
Access control and surveillance systems
Server, Storage & Backup
Server, storage and backup solutions
Voice & Video Conferencing
Voice and video conferencing systems
IoT & Automation
IoT and automation solutions
Software Development & Integration
Software development and integration
Practice Area · Data Integrity
Data Integrity
Comprehensive data integrity solutions to ensure accuracy, reliability, and compliance with regulatory standards.
Core Services
- ✓ SWOT & GAP Analysis, Risk Assessment
- ✓ Data Integrity Policies & Verification & Remediation's
- ✓ Preparation of Standard Operating Procedures
- ✓ Quality Management Systems (QMS)
- ✓ ALCOA++ Principal Assessment
- ✓ Continuous Monitoring Procedures for Data Integrity
- ✓ Audit Trail Review Methodologies
- ✓ Access Control and Security Assessments
Why Data Integrity Matters
Ensures regulatory compliance with FDA, EMA, and GxP requirements
Maintains data accuracy and reliability throughout the lifecycle
Prevents data manipulation and ensures audit trail integrity
Protects against regulatory penalties and compliance failures
Practice Area · Auditing & Compliance
Auditing Services
Comprehensive auditing services to ensure GxP compliance and financial control standards.
GxP Compliance Auditing
Comprehensive auditing services to ensure GxP compliances across all regulated processes and systems.
- • GMP (Good Manufacturing Practice) audits
- • GLP (Good Laboratory Practice) audits
- • GCP (Good Clinical Practice) audits
- • System and process compliance reviews
SOX Compliance
SOX compliance for internal financial control, ensuring your financial systems meet regulatory standards.
- • Internal financial control assessments
- • Financial system validation
- • Compliance documentation and reporting
- • Risk assessment and mitigation
Ready to get started?
Let's discuss how our comprehensive CSV consulting and services can help ensure your systems are compliant, secure, and validated.