GxP & CSV Validation

Computer System Validation (CSV)

AdviniaTech provides expert Computer System Validation (CSV) consulting to ensure life sciences infrastructure meets FDA 21 CFR Part 11 compliance, EU Annex 11 compliance, and GAMP 5 validation guidelines. Secure high-level data integrity in pharma, guarantee product quality, and secure regulatory audit readiness.

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Modern FDA Framework

Computer Software Assurance (CSA)

Transition from traditional CSV to the FDA's Computer Software Assurance (CSA) framework. Our approach streamlines software verification by shifting focus from documentation-heavy paper trails to critical thinking and a modern risk-based validation approach.

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Compliance Auditing

GxP Assessments & Audit Support

Ensure audit-ready validation services with our comprehensive GxP compliance validation gap assessment. We specialize in mock inspections, SOP remediation, and data integrity audits to align your software systems with GMP, GLP, and GCP regulations.

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About Company

Specialist Life Sciences Validation & Regulatory Consulting

AdviniaTech is a specialist regulatory consulting and validation staffing firm dedicated to the Life Sciences & Pharmaceutical systems domain. We help regulated-industry clients achieve full GxP compliance, execute computerized systems validation (CSV/CSA), and deploy specialized validation talent to maintain audit readiness.

Our Vision

To be the premier partner for life science technology compliance and CSV validation staffing across global pharmaceutical and biotech markets.

Our Mission

To deliver GxP-compliant digital systems and specialized validation talent that empower life science organizations to innovate without compromising regulatory standards.

AdviniaTech Global Delivery World Map
What We Do Best

Our Core Service Offerings

Built around primary compliance practices — GxP computerized validation, specialized validation staffing, and regulatory consulting audits.

Life Sciences & Pharma GxP Validation

Specialist GxP compliance consulting, Computer Systems Validation (CSV), Computer Software Assurance (CSA), and validation lifecycle management for pharmaceutical, biotech, and medical device systems.

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IT Services

Custom software development, GxP-compliant cloud infrastructure, and direct validation support for LIMS/ERP/MES software integration, delivered to support validated environments.

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Global Staffing

Accelerate your projects through our specialized global staffing solutions. As a trusted partner among CSV staffing agencies, we deploy pre-vetted CSV engineers, GxP validation consultants, and quality assurance leads in days.

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Execution Blueprint

Our Delivery Process

From scoping to audit handoff, we follow a transparent five-stage validation lifecycle.

01
Discover

Requirements definition, computer system mapping, and validation strategy outline.

02
Plan

Validation Master Plan (VMP) drafting, risk assessment, and IQ/OQ/PQ protocol design.

03
Develop

Validation protocol execution, test script design, and compliance verification checks.

04
Deploy

Drafting Validation Summary Report (VSR), standard SOPs, and final compliance sign-off.

05
Support

Ongoing change control audits, regular validation checks, and inspection readiness support.

Start Your Journey

Please reach out to us.

+91 8806661447 (Shounak)
+91 9850951857 (Tushar)
Shounak.panse@adviniatech.com
tushar@tusharingle.com

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