Authoritative Guide to Veeva "End-User" Validation
Veeva Validation Challenge!
Veeva is a powerful cloud platform that can span the entire drug life-cycle (from R&D to Commercial). It is a multi-tenant platform that is constantly evolving - at least three to four new releases a year. Veeva provides a good vendor validation package that you as a customer can leverage. There is only one caveat - the end-user company is still responsible for Veeva validation and cannot pass the buck to the vendor. In other words, you are responsible for the GxP validation of your instance.
Why is “End-User” validation of Veeva a challenge?
The “last mile” validation of a multi-tenant cloud platform like Veeva at a minimum involves establishing that the “intended use” of your instance was met at initial deployment. This is not too bad, right. A validation plan, user requirements specification, configuration specification, user acceptance testing, and traceability matrix will do the trick! But what about change control of your instance? There are 3 or 4 new releases a year.
The challenge is how to ensure your intended use is met with every new release? There are features that are “auto-enabled” and there are features that can be turned on by you if you choose to. Here is your conventional model to tackle changes that come with every new release:
Perform Compliance Analysis to identify the impact of new features and changes
Based on your risk-based approach, clearly identify the tests that make up the regression suite.
Identify what new test cases have to be created, what existing ones need to be updated.
Update your specifications and other documents.
Manually execute your regression suite along with the new/changed test cases.
Prepare a summary report.
Performing the above-mentioned tasks 3 to 4 times a year to stay in a validated state is not fun and sucks up a lot of resources. You then begin longing for the on-prem version where the upgrade cycle may be a few years (not a few months). Veeva cloud is supposed to bring in a new era of constant innovation to help you constantly increase your productivity! This is not what I am seeing on the “ground” on the validation front.
Why is xLM TestOps an ideal solution to this End-User Validation Challenge?
“The challenge is how to ensure your intended use is met with every new release?”
xLM TestOps was designed for cloud platforms like Veeva from ground up. It incorporates agile frameworks designed for GxP Compliance. Best of all it is provided as a managed service so that you can rest in peace and not worry about the nitty gritty details about test automation.
What is xLM TestOps?
xLM TestOps is built on modern Software Testing frameworks. It leverages both API based as well as UI based test automation. We balance the right mix of API and UI based test automation to optimize on efficiency while not compromising on compliance.
Our initial end-user validation package includes user acceptance testing that is built on DevOps pipelines and 100% test automation.
How is xLM TestOps different from conventional validation?
To begin with, manual validation testing has been removed and is replaced with a continuous validation managed service built on modern software testing frameworks. The mantra is “use software to validate software”!
Running a regression suite takes minutes and not days.
TestOps provides at a minimum 10x the coverage compared to manual testing and incorporates sophisticated techniques: Combinatorial Testing, Multi-Browser/Multi-OS Testing, Randomized Testing, Data Driven Testing, etc..
All this comes at a fraction of the cost (our customers are enjoying over 50% in cost savings) and delivered at speed.
How is it done?
Step 1: As soon as the new version hits the Veeva Sandbox, we run the TestOps pipeline (DRY RUN) which incorporates 100% regression testing. Within minutes we will inform you of the impact of the new release on your intended use. This includes the impact of all auto-enabled new features.
Step 2: Based on the Step 1 results, any adjustments to the existing validation stack including test scripts are made.
Step 3: A formal run which incorporates 100% regression suite. A summary report is generated to validate the new release.
Step 4: Steps 1 to 3 are repeated if needed to validate any new optional features.
Conclusion
“Conventional validation methods based on rusty manual testing is akin to fighting a forest fire with a garden hose.”
Conventional validation methods based on rusty manual testing is akin to fighting a forest fire with a garden hose. It just does not work! You need a sophisticated software platform to implement continuous validation for Veeva at a price point well below traditional validation. The ultimate measure of success is when the End-User validation is transparent to the end-user.