May 6, 2011

More on Computer Validation

Posted in Computer Validation at 7:54 AM by Solutions2Projects, LLC

Every day provides us with an opportunity to learn and grow.  Each time there is an issue on a project, we reflect on what we could have done differently to avoid the issue in the future or mitigate the impact.  A recent client project was no exception.

We were asked to participate in a project as individual contributors rather than driving the project for the client.  Other vendors with more experience with the software/system were assigned tasks that we typically handle but we (the client and I) assumed they would be more efficient and better suited to handle the tasks.  We were wrong. 

What we learned is that not everyone can write a good validation test script even if they claim to have been doing it and other clients have been satisfied with the scripts.  Apparently, other clients don’t actually read the scripts and verify the tests confirm requirements.  Test script development is fairly basic from our perspective.   

  • Define the objective
  • Establish acceptance criteria (usually tied to requirements)
  • Create specific action steps for the tester
  • Document expected results based on what should happen as a result of the action
  • Add assumptions and pre-requisites to ensure smooth set up and execution

Most importantly, actually verify the requirements are verified in the tests.  Screen shots of available functions do not actually confirm functionality. 

It seems that some vendors have been more focused on checking the proverbial boxes  than producing value-added validation deliverables.  No wonder most people groan, cringe, and look for ways to avoid computer validation.  Vendors and some internal computer validation staff are not looking at computer validation as an opportunity to increase the likelihood of success of a system but as a time consuming, paper generating, waste of resources.

Computer validation is designed to provide organizations with a high degree of confidence that the system they implement meets the requirements and is maintained in a controlled fashion.  This is done by

  • Defining the requirements
  • Configuring/developing to the requirements
  • Testing to verify the requirements are satisfied
  • Controlling changes to the system

While there are regulatory requirements that mandate computer validation, the investment decreases overall cost over time and increases the likelihood that your organization will get what it wants and needs in a system.  I continue to argue that if done well, computer validation makes good business sense by driving good selection, implementation, and maintenance practices for IT related systems. 

On this particular project, we tried to work with the client to reduce costs and time by utilizing the vendors canned requirements and test scripts (it’s a standard in the industry with very few variations across organizations) only to learn that the requirements were not fully tested in the standard test scripts and were not well written.  Solutions2Projects stepped in to rework the test scripts and create new ones to satisfy the requirements.  The client is now satisfied and has a defendable validation package.  Next time, we won’t make the same mistake.

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