IT Compliance & Computer System Validation (CSV)
At Avacone India Technologies, We help organizations ensure their IT systems meet strict regulatory compliance through meticulous validation and documentation. Our CSV services are designed to support GxP-regulated industries such as pharmaceuticals, life sciences, biotechnology, and healthcare, ensuring full audit-readiness and operational integrity of computerized systems.
System Validation for GxP Regulated Environments
We specialize in Computer System Validation (CSV) tailored for GxP-regulated industries including pharma, medical devices, and healthcare. Our validation strategies are aligned with FDA 21 CFR Part 11, EU Annex 11, and other global regulations.
From validating laboratory software to manufacturing systems and clinical applications, our experts ensure compliance while maintaining system efficiency and reliability.
Key Offerings
GxP-compliant CSV strategy and roadmap
Validation of LIMS, ERP, MES, and other GxP-critical systems
21 CFR Part 11 assessment and implementation
Audit trail review, ALCOA+ principles adherence
IQ, OQ, PQ execution for regulated environments
Complete Validation Documentation Suite (URS TO PQ)
We offer a full suite of validation documentation services—starting from the User Requirements Specification (URS) through to Performance Qualification (PQ). Our documentation meets global audit expectations and is customized to your system’s complexity and risk level.
Each document is prepared under strict version control, with traceability, sign-offs, and electronic records complianc
Key Offerings:
- URS, FRS, Design Specs (DS), RTM, IQ, OQ, PQ documentation
- Validation Plan (VP) and Validation Summary Report (VSR)
- SOPs, risk assessments, change control documentation
- Trace matrix mapping and deviation handling
- Compliance with ISO, GAMP 5, FDA, and WHO standards
Validation for IT Infrastructure, Cloud & SaaS Tools
With the rapid adoption of cloud-based technologies, validating infrastructure and SaaS platforms is essential for regulatory compliance. We help you validate AWS, Azure, Office 365, Salesforce, and other tools by applying scalable and risk-based validation frameworks.
Our team ensures data integrity and compliance across all layers—physical, virtual, and hosted.
Key Offerings:
- URS, FRS, Design Specs (DS), RTM, IQ, OQ, PQ documentation
- Validation Plan (VP) and Validation Summary Report (VSR)
- SOPs, risk assessments, change control documentation
- Trace matrix mapping and deviation handling
- Compliance with ISO, GAMP 5, FDA, and WHO standards
- Cloud-based system validation (Azure, AWS, GCP, SaaS platforms)
- Validation of backup, recovery, and access control systems
- Virtualization validation (VMware, Citrix, Hyper-V)
- Assessment of data integrity controls in cloud & hybrid environments
Quality Risk Management & Compliance Monitoring
Our CSV services are grounded in robust risk management methodologies. We identify critical control points, assess system risks, and implement mitigation measures to maintain ongoing compliance throughout the system lifecycle.
Through proactive audits, periodic reviews, and automated compliance tracking, we ensure your systems remain within regulatory thresholds at all times.
Key Offerings:
- GxP-focused risk assessments and mitigation plans
- Periodic review schedules and system revalidation
- Internal audit support and compliance scorecards
- CAPA management and deviation tracking
- Monitoring tools for change control and continuous compliance
