From change control to IQ/OQ/PQ — one team, one audit trail. Built for FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
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A single partner for pharmaceutical compliance — covering both the software you run on, and the validation evidence that keeps it audit-ready.
Metariki Innovitech Private Limited is dedicated to building innovative digital solutions and validation services for pharma manufacturing plants. Our mission is to streamline quality, production, engineering, and HR processes with cutting-edge technology and compliance-driven systems — backed by an in-house Computer System Validation practice that gets every rollout audit-ready.
Comprehensive QMS for compliance and efficiency.
Advanced QC tools for pharma labs and production.
Streamlined microbiology workflows and records.
Optimize manufacturing with real-time insights.
Maintain and monitor plant engineering systems.
Efficient HR and admin processes for pharma teams.
We offer comprehensive Computer System Validation for regulated industries, with deep expertise in GMP CSV. Our practice ensures your computerized systems consistently meet FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 — protecting data integrity, electronic records, and audit readiness across the product lifecycle.
Evaluate existing systems for validation gaps.
Determine GxP impact and testing scope.
Develop VMP, URS, and validation strategy.
IQ, OQ, PQ under QA supervision.
Finalize FVR and traceability for audit readiness.
Change management and periodic review.
Pharma manufacturers we work with.
Built for pharma industry standards and regulations.
Modern, scalable, and user-friendly solutions.
One partner for both your eQMS rollout and the CSV evidence that gets it audit-ready.
Dedicated support for seamless operations.
Mumbai, Maharashtra, India
info@metariki.in