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Validation Phase and its Types

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INTRODUCTION

Validation phase is considered as one of the most important phases in the process of project management, in which process is performed in either one step or multiple steps. This phase of project management is performed to determine and validate that the weather project is meeting its specification or not. Validation phase keeps documented evidence of processes that have been performed effectively and efficiently to fulfill the requirements of the project.  CSU (Charles Sturt University) also involves subjects related to validation phase in different courses of Bachelor’s and Master’s degrees. The main aim of this phase is to ensure that final products consistency is according to the client’s expectations and this aim can be achieved by performing three processes of validation phase as discussed below:

  1. Process Design: This stage in the validation phase is known for its development and research tasks performed also it involves defining processes that are required for the manufacturing of products. It usually performs three main activities that are Defining profile of quality of target product in which it is briefly explained that what kind of product is needed and its behavior secondly, it defines critical quality attributes that is considered important to meet target profile, thirdly it defines parameters for critical process in which limitations are defined that occur in project and while defining this property it considers features of equipment’s and machinery used.
  2. Process Qualification: Main focus of this stage is to qualify the designed process to ensure that again produce reliable and consistent levels of quality. This process involves the collection and evaluation of data for all the aspects of the manufacturing This process includes transportation and storage of raw material and provides training to employees about product and manufacturing processes. The output of every step turns raw material into a finished product that can be further used for the next process.
  3. Process Maintenance: This process is also known as continued verification process which includes validation of ongoing processes during the production of commercial products so as to ensure that process designed in previous stages are still producing consistent quality for the product. The main aim of this process is to detect and resolve various drifts that are encountered in different processes. This process further involves sampling of product, analysis, and verification in the different manufacturing process and requires training and involvement of employees for a quality

TYPES OF VALIDATION PHASE

  • Prospective Validation: Scope of the prospective validation process is to establish documented evidence of the progress of activities performed by the system. This process is carried out on the basis of various preplanned protocols so that it can be implemented in the actual
  • Retrospective Validation: Purpose of this process is to perform the task of validation at the point when production facilities have not been validated previously and to avoid various issues related to non- confirmation.
  • Concurrent Validation: Concurrent validation is initiated when the first production is performed and till all established number of runs are completed. In this, all the critical steps performed during the process of production are monitored and end products are tested. This process is important as real-life scenarios are different from those in a testing environment which further increases the possibility of errors and unpredicted outcomes.
  • Revalidation: Revalidation is the process of repetition of all or some of the validation processes, it also includes a review of data that has been collected to measure the performance.

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