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Accelerate Veeva Vault Validation with Opkey's Automated Continuous Validation Platform

July 13, 2021
   /   
by 
Iffat Ara Khanam

Modern laboratories and healthcare centers rely on computer applications like Veeva Vault to process and manage data. Validating systems like Veeva for operational qualification (OQ) and performance qualification (PQ) is a time-consuming process. Furthermore, testing new releases and updates to the software is a major concern for business users and managers. In this blog, you will learn how test automation can help streamline the validation process and reduce the overall time and effort required for an application with strict compliance standards.

"We need four weeks to carry out specific processes to formulate the COVID-19 vaccine. With the help of advanced analytics and supercomputing platforms, we’re able to reduce that time to 18 hours. Within two to three days, we’re ready for FDA review" - Pfizer CEO

Frequent updates creates risk for Veeva critical business processes

Every three to four months, Veeva releases offers new features, functionalities, customer enhancements, and application maintenance as updates. As a conscientious software vendor, Veeva provides release documents to help customers, including a validation plan, test protocol, traceability matrices, and a validation summary report. These documents make the validation process easier, as end users are responsible for validating their Veeva instance works properly after an update.

Keep these tips in mind as your prepare for a Veeva validation:

  • Business continuity is only ensured once you thoroughly test your Veeva processes.
  • Any Veeva configuration change or software release expose your business to unnecessary risk by altering IQ, OQ, and PQ workflows, or preventing update validation.
  • Testing new releases and updates prevents compliance gaps.
  • Organizations should maintain an adequate level of documentation for regulatory compliance.

Veeva validation – a long, time-consuming, and costly process

Veeva business processes must be validated across their ecosystem of applications, and through integrations with other apps. Most applications are manually tested in silos, ignoring their key integrations with supporting apps, like Salesforce. Manually validating a CSV system takes too long and testing can only be completed on-time by using automated testing. Since Veeva is developed on the same framework as Salesforce,  the s-controls, the forms, and UI elements in Veeva have very dynamic properties. Due to nested or hidden frames, the average automated test script for a business process requires hours of coding and has a high probability of causing a broken or brittle automation script.

The Solution: Automated Continuous Validation

You will receive an OQ validation report from Veeva with each update. Continuous configuration changes and Product Qualifications (PQ) are still the end user's responsibility, and Opkey's automated test platform provides support for that type of testing.

Watch Opkey's video introduction to show how continuous automation helps with each Veeva release.

"Opkey is being used by global pharma and life sciences companies to accelerate the validation of their QMS & Trial management systems like Veeva. With Opkey, cycles get drastically reduced and testing costs declined by 38% in 1 year".

Opkey is the industry's first automated continuous validation platform for GxP compliance solutions like Veeva CRM/ Veeva Vault. GxP compliance is the cornerstone of the pharma and life science industries. Opkey's continuous test platform helps life science and pharmaceutical companies complete successful configuration validation, which supports their traceability and accountability in the industry.

From a technical side, Opkey's platform offers several features to make Veeva validation easier. There are of course, integrations with over 15+ technologies, including ALM/JIRA and end-to-end integration testing for 14+ popular packaged applications like Salesforce, Oracle and SAP.  But, that's not all. Opkey's Veeva validation success is supported through the following options:

  • Pre-built test accelerators to help automate OQ/PQ: Opkey has a library of 1,000+ pre-built test accelerators for Veeva testing and 130+ pre-built automated OQs available across pharmaceutical QMS applications.
  • Risk-based CSV with real-time change impact analysis: Opkey provides predictive analysis, comparing an organization’s “as-is” processes and their “to-be”processes around a Veeva software update, highlighting which processes and customizations will be most at risk after an update. This will guide test plan development so the processes with the most risk can be tested first.
  • Analytical reporting: Opkey’s validation package includes a validation plan, validation summary report, and executed OQs and IQs with their respective evidence. Opkey supports agile CSV processes with a data-driven approach, providing real-time insight with custom reporting and compliance for regulatory standards. Opkey offers full audit trails with automated screenshot capturing for each test execution and an out-of-the-box validation report format to meet your CFR21 Part 11 requirements.
  • End-to-end enterprise integration: Opkey’s testing supports critical integrations with clinical trials, Labs/LIMS/LIS, claim processing unit, and tools like ADFI Reuters, Web ADI, REPS, and Intermix. Real-time JIRA integration allows for full traceability of the testing process, from beginning to end.
  • No-code test editor for business users and testers: Opkey offers the industry’s best test builder/record-and-playback engine and an advanced test creator. Opkey's drag-and-drop test builder allows users who are not code-literate to build tests in their native applications, such as Veeva, and test processes that interact with other applications, like Oracle, SAP, Salesforce and other ERPs.
  • Real-time testing: Opkey's Veeva-specific record-and-playback engine reads and interprets documented test scripts, executing test cases against the system in real-time. Furthermore, the drag-and-drop feature allows users to call up Veeva-specific keywords to write complex tests and save them to the testing library. These tests can be called from the test library and run over and over again, saving testers time. Automated tests can also be run in parallel, allowing more tests to run in the same span of time. 

With Opkey, you can easily achieve better business outcomes, compliance, and complete end-to-end Configuration Validation for Veeva tests. Using Opkey, you will have complete data validation coverage for each configuration cycle and reduce your overall regression cycle test time by over 50%.

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Dimpy Sharma
AVP, Opkey
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SVP, Excelencia Consulting
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Oracle Application Database Administrator, Excelencia Consulting
Manoj Samuel E
Delivery Manager, Excelencia Consulting
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