Pharma
Computer System Validation (CSV)
and
Computer Software Assurance (CSA) Services

X Pharma Plus provides expert Computer System Validation (CSV) and Computer Software Assurance (CSA) services for life sciences organizations. We help pharmaceutical, biotech, and healthcare companies ensure regulatory compliance, streamline software development lifecycles, and maintain data integrity across all systems.

 Pharma Computer System Validation (CSV) and Computer Software Assurance (CSA) Services – Overview

Ensuring that software and computerized systems meet global regulatory requirements is critical in the life sciences sector. Companies must validate software for proper functioning, adherence to quality gates, and compliance with regulations such as 21 CFR Part 11, 21 CFR 820, and GAMP 5. X Pharma Plus supports organizations throughout the software lifecycle, from initial development to compliant final versions, offering both traditional CSV and modern CSA approaches.

Our team performs software verification and validation, GMP software validation, process validation, and retro validation for legacy systems. We provide documentation, audit readiness, and regulatory guidance to ensure that all systems meet global compliance standards.

 Pharma Computer System Validation (CSV) and Computer Software Assurance (CSA) Services

“Comprehensive Pharma Computer System Validation (CSV) and Computer Software Assurance (CSA) Services ensuring data integrity, regulatory compliance, and reliable system performance across all GxP environments.”

  • Computer System Validation (CSV): Progressive validation per FDA, EU, PIC/s, GAMP 5, ICH, WHO, 21 CFR Part 11, and EU Annex 11 Supports simple to complex projects using Waterfall or Agile methodologies.
  • Computer Software Assurance (CSA): Modern CSA processes for seamless regulatory compliance and software assurance, aligned with FDA expectations.
  • Software Validation Verification: Objective assessment to confirm software meets intended use and regulatory standards.
  • GMP Software Validation & Process Validation: Ensuring software and processes in manufacturing and biopharmaceutical production comply with regulatory standards.
  • Retro Validation: Retrospective validation of legacy systems to fill documentation gaps, align with GAMP 5, and ensure audit readiness.
  • GxP and ERES Assessments: Evaluate electronic records/electronic signatures, audit trails, business continuity, disaster recovery, and vendor compliance.
  • Vendor Audit and Qualification: Assess and validate software vendors, facilities, and manufacturing processes.
  • Ensures regulatory compliance, product quality, and patient safety.
  • Maintains data integrity, security, and audit readiness.
  • Leverages experienced professionals with deep expertise in CSV and CSA.
  • Offers integrated process models and proven validation strategies.
  • Provides rapid turnaround times and significant cost efficiencies.

X Pharma Plus delivers end-to-end CSV and CSA solutions that empower life sciences organizations to confidently deploy software and computerized systems while remaining fully compliant with global regulatory standards.

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