Computerized System Validation: Introduction Implementation and Regulations – A Review

Author(s)

Todkar, V. S., Lade, M. S., Patil, K. S., D’souza, J. I.

Author's Affiliation

Abstract

Computerized System validation covers the equipment those are having their own Control systems based Software Systems. It defines the extent of the validation program and lays down broad guideline for the various validation activities to be carried out. This provides a framework and practices for validation and qualification of Computer based software systems. The validation master plan is the basis of individual project validation plans, also called master validation plan. This plan states regulatory expectations for the activities, tasks, and testing to be performed during validation of Software Systems. This document provides broad guidelines to be followed and implements the concept for Software System validation as per the best understanding of Good Automated Manufacturing Practice, Version 5 (GAMP 5) & Part 11 regulation (wherever applicable). Computer system validation provides recognized proof that the systems will repeatedly and consistently do what it is deliberate to do, is "fit-for-purpose", and complies with the applicable rules and regulations. Computer system validations have many advantages like improve quality, reduce other validation outlay and time, improve GMP compliance and 21 CFR part 11 regulation which has impact on product quality, safety, identity or efficacy that subject matter to GxP rules. It is likely that the future will see meeting of computer system validation terminology and techniques as a common technical discipline across other industry sectors as well.

Keywords

Computer System Validation, Good Automated Manufacturing Practices, Quality Assurance, Validation Life Cycle

Cite This Article

Todkar, V. S., Lade, M. S., Patil, K. S., & D’souza, J. I. (2014). Computerized System Validation: Introduction Implementation and Regulations - A Review. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(3), 122-131.