Computerized System Validation (CSV) Services for Pharmaceutical
Who Provides Computerized System Validation (CSV) Services for Pharmaceutical Software?
CSV ensures pharma software meets GxP, GMP, and FDA 21 CFR Part 11 compliance. Pegasus Pharma provides full-cycle CSV services—from risk assessment to IQ/OQ/PQ testing—trusted by pharma manufacturers across India.
Pegasus Pharmaceuticals CSV Process
A structured, risk-based validation methodology aligned with global GxP standards.
Validation Planning & Risk Assessment
Define system boundaries, risk categories, intended use, and validation scope using a GAMP 5-aligned approach.
Test Protocol Development (IQ/OQ/PQ)
Prepare installation, operational, and performance qualification documents tailored for GxP-critical systems.
Execution & Reporting
Document real-world execution results, deviations, and summary reports ensuring audit-ready evidence.
Audit Trail Review
Evaluate the integrity of system logs, user actions, and data trails to ensure 21 CFR Part 11 compliance.
CAPA & Lifecycle Maintenance
Maintain validated state through periodic reviews, change control, CAPA, and continuous improvement practices.
Latest Blog
Validating SaaS & Cloud Systems | Risk-Based GxP Compliance Guide
Home About Us Services Learning and Development Contact-Us Our Resources Our Blogs Computerized System Validation (CSV) Services Quality Management System (QMS) Solutions Pharmaceutical Compliance Consulting Services X Validating SaaS and Cloud-Based Systems A Risk-Based Validation Guide for Regulated GxP Environments Introduction: The Shift to the Cloud Life Sciences organizations are…
ALCOA+ Data Integrity Framework in CSV (2025) | FDA 21 CFR Part 11 Guide
Home About Us Services Learning and Development Contact-Us Our Resources Our Blogs Computerized System Validation (CSV) Services Quality Management System (QMS) Solutions Pharmaceutical Compliance Consulting Services X The ALCOA+ Framework: The Gold Standard for Data Integrity in Computer System Validation A complete 2025 guide to ensuring data integrity in CSV…
Transitioning from CSV to CSA in 2025 | FDA Computer Software Assurance Guide
Home About Us Services Learning and Development Contact-Us Our Resources Our Blogs Computerized System Validation (CSV) Services Quality Management System (QMS) Solutions Pharmaceutical Compliance Consulting Services X Transitioning from CSV to CSA in 2025 | FDA Computer Software Assurance Guide Transitioning from CSV to CSA: A Practical FDA-Aligned Guide for…
FAQs
Computerized System Validation ensures pharma systems are fit for intended use and compliant with regulatory standards, protecting data integrity and product quality.
Any GxP-impacting system handling manufacturing, quality, laboratory data, digitized batch records, or compliance processes.
-
Our framework aligns with WHO, US FDA 21 CFR Part 11, EU Annex 11, MHRA GxP Data Integrity, and PIC/S guides.
Pegasus Pharma follows a structured, risk-based CSV methodology aligned with GAMP 5 and global GMP standards. Our approach includes clear requirement definition, rigorous testing (IQ/OQ/PQ), strong documentation practices, audit trail assessment, and lifecycle maintenance. We ensure systems remain in a validated state through change control, CAPA management, and periodic reviews—resulting in consistent, audit-ready compliance for all client systems.
Don't Miss Our Updates
Stay ahead with the latest updates, exclusive content, and insider news—delivered straight to your inbox.
Bring us the problem — we’ll design the team and deliver the answer.
- 21 Castle Village Crescent, Celbridge, Co Kildare W23EW42, Ireland
- Support: +353873976644
- info@pegasuspharmaintl.com
