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Computer System Validation (CSV) Services

Ensuring Compliance & Data Integrity with Comprehensive CSV

In today’s regulatory environment, ensuring that computerized systems meet compliance standards is crucial for pharmaceutical, healthcare, and life sciences industries. At VMT Soft Solutions, we offer end-to-end Computer System Validation (CSV) services to help organizations achieve compliance with USFDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other regulatory standards.

Why Computer System Validation?

  • Ensures data integrity, security, and reliability of computerized systems.
  • Helps in regulatory compliance and avoids non-compliance penalties.
  • Reduces risks associated with software failures and data inconsistencies.
  • Enhances system efficiency, accuracy, and operational excellence.
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Our CSV Service Offerings

Full CSV Lifecycle Implementation

We provide complete validation services, covering the entire lifecycle of computer systems:Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

  • Validation Master Plan (VMP) – Defining validation approach and scope.
  • User Requirement Specification (URS) – Capturing system requirements.
  • Risk Assessment (RA) – Identifying potential compliance risks.
  • Functional Requirement Specification (FRS) – Defining system functionalities.
  • Design Qualification (DQ) – Verifying system design meets requirements.
  • Installation Qualification (IQ) – Ensuring proper system installation.
  • Operational Qualification (OQ) – Testing system functionality under standard conditions.
  • Performance Qualification (PQ) – Ensuring the system performs reliably under real-world conditions.
  • Traceability Matrix (TM) – Mapping requirements to validation testing.
  • Final Validation Report – Comprehensive documentation for audits.

2. Risk-Based Validation Approach

Our CSV strategy follows a risk-based approach aligned with GAMP 5 guidelines, ensuring validation efforts focus on critical systems and compliance requirements.

3. Audit Readiness & Compliance Support

We assist in audit preparation, ensuring your systems comply with regulatory bodies like USFDA, MHRA, EU GMP, and WHO. Our team provides GxP compliance assessments, periodic re-validations, and documentation support for successful regulatory audits.

About Us

VMT Soft Sol Pvt. Ltd. specializes in eQMS Software for the pharmaceutical industry. We simplify compliance, enhance efficiency, and ensure operational excellence.

Services

  • Training
  • Audit
  • CSV
  • Internship

QMS Solutions ​

  • Quality Management System (QMS)
  • Document Management System
  • Learning management system
  • Batch Record Management System
  • Laboratory Information Management System
  • Calibration Management System
  • Breakdown Management System
  • Preventive Maintenance Program
  • Annual Product Quality Review

Location Address

# 8-3-167/A/52, 2nd Floor, Vani Nilayam, Vikaspuri, AG Colony Road, S R Nagar(PO), Hyderabad-500038.
Phone Number : +91-9866968830

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