Computer System Validation (CSV)

With increasing regulatory scrutiny and the need for compliance in pharmaceutical, healthcare, and manufacturing industries, Computer System Validation (CSV) ensures that computerized systems operate consistently, reliably, and in line with regulatory requirements. As a trusted validation partner, we offer end-to-end CSV solutions that help organizations comply with FDA, EU GMP, ICH, ISO, PIC/S, GAMP5, and WHO guidelines.

Our CSV Offerings

Regulatory-Compliant Computer System Validation

We provide thorough validation services to ensure that your systems meet global regulatory requirements, covering:

Laboratory Systems –Ensuring software for research, testing, and quality control meets compliance standards.
Manufacturing SystemsValidating software involved in pharmaceutical and medical device production.
Quality Management Software –Supporting compliance with FDA-required Quality Management Systems.
Clinical Systems –Validating systems managing clinical trial data.

CSV Life Cycle Management

We follow a structured life cycle approach for CSV, ensuring compliance from system implementation to retirement:

Planning – Define scope, develop validation strategy.
Requirements & Design –Establish system, user, and functional requirements with risk assessment.
Testing & Deployment – Develop protocols, conduct validation, and implement controlled releases.
Maintenance & Change Control –Ensure system performance and compliance with regulatory updates.

Risk-Based Validation Approach

Our validation process identifies, evaluates, and mitigates risks associated with computerized systems, focusing on:

Operational, safety, and security risks
Risk severity, probability, and detectability
Implementation of mitigation strategies

Comprehensive Documentation & Compliance

We provide complete validation documentation to meet regulatory and audit requirements, including:

Master Validation Plan (MVP)
Initial Risk Assessment (IRA)
Validation Plan (VP)
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
Requirement Traceability Matrix (RTM)
Validation Summary Report (VSR)
Electronic Record & Signature (ERES) Compliance Assessment

Why Choose Us?

Expertise in Regulatory Compliance – Ensuring adherence to global guidelines.

Comprehensive Validation & Documentation – Covering all phases of CSV life cycle.

Risk-Based & Cost-Effective Approach – Optimizing compliance while reducing risk.

Proven Track Record – Successfully delivering CSV solutions for various industries.

With our Computer System Validation (CSV) services, you can ensure compliance, minimize risks, and optimize system performance while staying audit-ready.