Computer System Validation in Pharmaceutical Industry

CSV is the process of testing/validating/qualifying regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records.

The validation process begins with planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.

Tools and strategies necessary and appropriate for use in the validation of computerized systems related to compliance with Good Practices (GxP).

  • Manufacturing (GMP)
  • Clinics (GCP)
  • Laboratory (GLP)
  • Good Distribution Practices (GDP)
  • Storage (GWP)
  • Documentation (GDP)

Regulatory specific expectations for CSV

  1. Regulatory Compliance: All computer systems used in the design, manufacture, packaging, labelling, storage, installation should comply with 21 CFR Part 11 and other relevant regulations.
  2. Validation Documentation: Maintain comprehensive documentation of the validation process, i.e validation plans, system specifications, test protocols, test results. The documentation should be sufficient to demonstrate that the system is validated and operates correctly.
  3. Risk Assessment: Perform risk assessments to identify the potential impact of system failures on product quality, patient safety, and data integrity.
  4. Data Integrity: CSV processes will ensure data integrity. This includes generating accurate and reliable data, preventing unauthorized access or changes to data, and maintaining audit trails.
  5. Change Control: Any changes to the system, including software updates or changes to hardware, should be documented and validated to ensure that they do not adversely affect system performance.
  6. Training: Individuals responsible for the design, operation, maintenance, and validation of computer systems are adequately trained to perform their duties.
  7. Periodic Review: Companies to periodically review validated systems to ensure they remain in a state of control and continue to meet their intended purpose.
  8. Vendor Assessment: If third-party software or systems are used, companies to assess the vendor’s ability to provide a product that will meet the user’s requirements and regulatory expectations.


  • EMA Guideline on computerised systems and electronic data in clinical trials
  • EudraLex Volume 4 GMP Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems
  • PIC/S GMP for Computerised Systems
  • FDA, Title 21 CFR Part 11

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Resource Person: Dr.Prasadhi Shiva

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