Computer system validation (CSV) is a documented process that a computer system should meet a set of defined system requirements.

Validation of computer systems is done to ensure their accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. It is a critical requirement for electronic record compliance.

Our computer system validation experts validate computer programs for all types of businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories. Regulatory agencies require the CSV process to ensure the accuracy and integrity of data in computerized systems and product safety and effectiveness. CSV should be done at the time of configuring a new system or updating an already validated system (upgrades, patches, extensions, etc.).

CSV processes should be done as per the regulations and guidelines. Best practices for the domain and the attributes of the system are being approved.

Case Study on Manufacturing/Quality Systems Validation



Regulatory guidelines Vs Current practices/SOPs Vs Current practices.



Reusable documentation, CSV Validation as per 21 CFR Part 11, EU Annex 11 & GAMP 5



Conduct periodic reviews. Change Management and continuous Audit readiness.

Validation Activities under the current scope;
  • RRA - Regulatory Risk Assessment
  • FRA - Functional Risk Assessment
  • IQ - Installation Qualification
  • OQ - Operational Qualification
  • PQ - Performance Qualification
  • QRM - Quality Risk Management
  • DIRA - Data Integrity Risk Assessment
Associated with Major Indian Pharma Companies Across different locations in India Total 4000+ Systems covered ;
  • HPLC
  • GC
  • HMI
  • Chromeleon
  • LabSolutions server
  • Empower
  • CDAS and
  • Serialization systems
Validation Deliverables as per current scope;
  • VMP - Validation Master Plan
  • EAR - Electronic-data Assessment Report
  • VAR - Vendor Assessment Report
  • SVP - Software Validation Plan
  • URS - User Requirement Specification
  • FRS - Functional Requirement Specification
  • DS - Design Specification
  • CS - Configuration Specification
  • RTM - Requirements Traceability Matrix
  • VSR - Validation Summary Report
  • SRC - System Release Certificate (SRS)
  • TL - Transport Log
  • PRR - Periodic Review Report

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