Delivering Audit-Ready Computer System Validation for India’s Pharma Industry
Ensure compliance with GxP, 21 CFR Part 11, and GAMP 5 through validated process control, laboratory, and enterprise systems.
MedTech CSV
Our Services
Documents Deliverable in CSV?
01
GxP Assesment
Identifying That system requires validation & System
catagorize as per GAMP-5.
02
Validation Plan
To prepare Detailed Validation plan for system.
03
System Requirement Specifications
To prepare Detailed System requirements specification for
system.
04
Risk Assessment
To prepare Risk assessment for initial & Functional Risk assessment.
05
Installation Qualification
To Verify that Installed System hardware & Software
components are proper.
06
Operational Qualification
To Verify that all functions & Operational run working
properly of systems.
07
Performance Qualification
To Verify that all functions & Performance of system is
Proper.
08
Validation Summary Report
Prepare Summary report after all Qualifications Run.
09
Traceability Matrix
Prepare Traceability report which will trace all Tests of
All Qualification activity.
10
System Release Certificate
System release certificate after all successful Tests.
About Us.
We provide Computer System Validation (CSV) and compliance services for pharma & life sciences. With GAMP 5, 21 CFR Part 11, EU Annex 11 expertise, we help you stay audit-ready.
Empowering businesses
Why choose MedTech CSV?
At MedTech CSV, we help pharmaceutical & life sciences companies achieve seamless compliance and reliable validation. Our solutions ensure that your systems are always audit-ready, efficient, and aligned with global regulations.
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Expert Validation Team– 100% focused on CSV, GxP compliance & pharma regulations.
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Audit-Ready Documentation– Documentation & systems that pass inspections confidently.
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Customized Approach – Validation strategies tailored to your needs.
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End-to-End Compliance Support – From gap analysis to training, we cover all stages.
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Trusted by Pharma – Partnering with companies who value quality & patient safety.
Our Core Services
• Process Control System Validation
• Laboratory Software Validation
• Enterprise Software Validation
ISO 9001:2015 Certified
