e-De-Risker

It’s a technology-driven world we live in today. Here, one witnesses the rapid evolution of technology and the generation of exponential amounts of data as a result of it. For instance, there’s an app for practically everything today! No wonder enterprises are making all possible attempts to understand how these apps behave in different situations.

Why is this understanding so crucial for enterprises? Simply because every organization needs a high degree of assurance of its processes to ensure consistent production, while meeting pre-determined quality specifications with minimal risk.

However, this understanding comes only by sieving through – and validating – huge volumes of data leading to eliminating risk scenarios. The idea is to accurately evaluate business risks and create quantifiable function points which are a combination of ‘criticality’ and ‘complexity.’ Also why organizations prefer to validate both introspectively and retrospectively.

e-De-Risker & eValidation: Validation estimating workflow

An overview

ValueLabs’ e-De-Risker is a comprehensive, web-based framework for computer system validation and risk assessment, and is based on the General Principles of Software Validation, a set of guidelines from the Food and Drug Administration (FDA) and International Society for Pharmaceutical Engineering (ISPE) and GAMP 5.

The e-De-Risker calculates the probability of occurrence of such risks and their severities through a risk-based, automated validation approach. This helps prioritize testing to mitigate risks, resulting in the e-De-Risker improving operational efficiency by a resounding 20% to 30%.

e-De-Risker allows user to export and import data from an internal system. Further, it identifies risks and calculates risk scores, which provides users with an opportunity to define varied risk scenarios. Based on the risk scores, it generates various kinds of reports in desired formats.

Key features

  • Evaluates, approves and determines quality scores with in-built workflow manager
  • Exchanges data using open web services
  • Facilitates integration with HP-ALM tool
  • Imports and exports data directly from an excel sheet
  • Provides consolidated dashboard that displays overall risk basis measured risks

e-De-Risker allows:

  • Superior user management
  • Risk scenario management
  • Function and sub-function management
  • Regulatory compliance through intensive data review

Download the e-De-Risker brochure to know more.