Overview

Equipment and Instruments Validation System

The primary challenge with traditional paper-based equipment validation is the lack of adequate visibility to the overall validation process and the validation status. During the equipment validation lifecycle, the industry faces the challenge to find critical data that is found in silos of data scattered across different paper based records to obtain key equipment lifecycle data and information. In addition, there is also need to assess the impact of changes to the validated state of the equipment during it lifecycle.  All these data elements are managed and tracked in disparate systems and documents and spreadsheets. With no clear validity of these data elements and lack of audit trail makes it extremely difficult to correctly assess and determine the validation status of the equipment.

Traditional paper-based equipment validation is very inefficient and not cost effective. Traditional paper-based equipment validation requires resources to dedicate a significant amount of their time to non-value manual activities, such as routing, printing, scanning and indexing documents. These manual activities are extremely time consuming, and inefficient. The following inefficiencies are typically found during the equipment and analytical instrument validation lifecycle

  • Manual protocol execution
  • Managing execution deviations through paper based process
  • Printing and Routing executed protocols documents for manual approval
  • Scanning documents into file folders and arching in document storage
  • Using uncontrolled Excel documents for tracking

Features

Efficient Equipment Validation through ValGenesis VLMS:

ValGenesis enables efficiency and cost reduction by facilitating a paperless validation lifecycle process. ValGenesis completely eliminates the inefficiencies that plagued paper-based validation processes. ValGenesis enables users to fully automate the entire equipment and analytical instrument lifecycle from Validation Planning to Decommissioning and Retirement. All manual activities such as printing, scanning and routing documents are completely eliminated with ValGenesis.

ValGenesis is a web-based system designed to eliminate the inefficiencies found in traditional paper based equipment and analytical instrument validation process. ValGenesis fully automates the entire equipment lifecycle and enable paperless equipment and analytical instrument validation lifecycle management.

Through ValGenesis companies can design workflows and decision tree that fully automate content protocol content generation and a risk based approach to equipment and analytical instrument validation. ValGenesis VLMS electronic protocol execution functionality enables users to use laptop or tablets to execute the protocol. Electronically identifies the engineer performing the execution of each test step with an electronic signature and date-time stamp. It can also enforce a verifier signature if needed. Also provides the ability to link or associate each executes test step with evidence like screenshots, file attachments, video and audio files. Additionally, execution failures can be managed by deviations workflows within the system.

Process

equipment-validation-lifecycle

 

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