I will perform computer system validation CSV as per gamp 5 and 21 cfr part 11

Samirali Meman

India

I speak Gujarati, English, Hindi

CSV, IT Compliance , ITQA

I am a detail‑oriented and proactive professional with 8 years of experience in the pharmaceutical industry, specializing in Data Integrity and IT Compliance. I focus on maintaining data accuracy, sys...
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About this Gig

Are you looking for a qualified professional to handle Computer System Validation (CSV) for your GxP regulated environment?

You're in the right place.

I offer end to end CSV documentation and compliance support following GAMP 5, 21 CFR P 11, Annex 11, and global pharma regulatory standards.

Whether you need a single document (URS, RA, VP) or a complete validation lifecycle package (URS RA VP IQ/OQ/PQ VSR), I ensure your system is audit ready, compliant, and aligned with industry expectations.

Services I Offer

CSV Documentation

  • User Requirement Spec.
  • Functional & Design Spec. (FRS/DS/CS)
  • Validation Plan
  • Functional Risk Assessment
  • Traceability Matrix (RTM)
  • IQ / OQ / PQ Protocols & Test script
  • Deviation & CAPA documentation
  • Validation Summary Report

Compliance Expertise

  • GAMP 5 categories & approach
  • 21 CFR Part 11 (ER/ES)
  • Annex 11
  • Data Integrity (ALCOA+)
  • Audit Preparation Support

Systems I Can Validate

  • LIMS/ QMS / ERP systems
  • SCADA / PLC / HMI
  • Lab/Mfg. equipment GxP software & Computer system

Why Choose Me?

Professionally written validation deliverables

Strong knowledge of GAMP 5 & Part 11

Structured, audit ready documentation

Detail risk based validation approach

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