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International Journal of Creative and Open Research in Engineering and Management

A Peer-Reviewed, Open-Access International Journal Supporting Multidisciplinary Research, Digital Publishing Standards, DOI Registration, and Academic Indexing.
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ISSN: 3108-1754 (Online)
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ISO Certification: 9001:2015
Publication Fee: 599/- INR
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License: CC BY 4.0
Peer Review: Double Blind
Volume 02, Issue 6

Published on: June 2026

COMPUTER SYSTEM VALIDATION: PROCESS, CHALLENGES, TOOLS AND FUTURE SCOPE

Amaresh Pradhan Sidhant Prasad Dash

GIFT Autonomous Bhubaneswar  Odisha, India 752054
DOI:https://doi.org/10.55041/ijcope.v2i6.094

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Plagiarism Passed Peer Reviewed Open Access

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Abstract

In modern industries such as pharmaceuticals, healthcare, and information technology, computer systems are widely used to manage important data and operations. It is very important to ensure that these systems function correctly and provide reliable results. Computer System Validation (CSV) is a process that confirms whether a system meets its intended requirements and works properly. The validation process includes different stages and requires proper planning and documentation. However, CSV also faces several challenges, including data integrity issues, system complexity, and strict regulatory requirements. The main aim of this paper is to describe the CSV process, highlight key challenges, and explain the tools used in validation. This study helps in improving data integrity, product quality, and patient safety.

Keywords—Computer System Validation; Data Integrity; Product Quality; Patient Safety; Pharmaceutical Industry

 

How to Cite this Paper

Pradhan, A. & Dash, S. P. (2026). Computer System Validation: Process, Challenges, Tools and Future Scope. International Journal of Creative and Open Research in Engineering and Management, <i>02</i>(6). https://doi.org/10.55041/ijcope.v2i6.094

Pradhan, Amaresh, and Sidhant Dash. "Computer System Validation: Process, Challenges, Tools and Future Scope." International Journal of Creative and Open Research in Engineering and Management, vol. 02, no. 6, 2026, pp. . doi:https://doi.org/10.55041/ijcope.v2i6.094.

Pradhan, Amaresh, and Sidhant Dash. "Computer System Validation: Process, Challenges, Tools and Future Scope." International Journal of Creative and Open Research in Engineering and Management 02, no. 6 (2026). https://doi.org/https://doi.org/10.55041/ijcope.v2i6.094.

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References


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  • FDA, Data Integrity and Compliance with Drug CGMP Guidance for Industry, U.S. Food and Drug Administration, 2018.

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  • PIC/S, Good Practices for Computerised Systems in Regulated GxP Environments, Pharmaceutical Inspection Co-operation Scheme, 2021.

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  • •All submissions are screened under plagiarism detection.
  • •Review follows editorial policy.
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  • •Peer Review Type: Double-Blind Peer Review
  • •Published on: Jun 07 2026
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