Modern laboratories and healthcare centers rely heavily on computerized systems like Veeva Vault to process and manage data. As validating systems like Veeva Vault for operational qualification (OQ) and performance qualification (PQ) is a time-consuming process. Furthermore, testing of new releases and updates is a major concern for business users and managers. In this blog, you will read how test automation can help to streamline the entire validation by bringing down the overall time and effort required to validate such regulatory applications.
“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 – More risk to critical business processes
Veeva offers new features, functionalities, customer enhancements, and maintenance items in the form of application updates that are rolled out at least three to four times a year. Though, Veeva is a good vendor that offers a set of release documents consisting of a validation plan, test protocol, traceability matrices, and a validation summary report. However, the end-user company is responsible for Veeva validation and cannot pass the buck to the vendor.
- Configuration changes and new software releases can alter IQ, OQ, and PQ workflows and affect the validated state, which leads business and customer to unnecessary risk.
- With every release, thorough testing of Veeva Systems is needed to ensure business continuity.
- Testing of new releases and updates prevents compliance gaps, enabling organizations to effectively manage changes while maintaining and managing an adequate level of documentation to defend the changes.
Veeva Validation – A long, time-consuming, and costly process
The ecosystem consisting of homegrown applications along with Veeva Vault, Veeva CRM, and other legacy applications is difficult to test manually. Furthermore, manually testing a CSV system needs a high turnaround time for completion of testing activities and hence automated testing becomes a relevant next step. Since Veeva is developed on Force.com technology that uses s-controls, the forms, as well as UI elements in Veeva, have significant dynamic nature of properties. And, due to these nested or hidden frames, if you need to create 30-50 steps in order to develop automated test scripts, you need hours of coding, and that usually results in a brittle test automation script.
The Solution: Automated Continuous Validation
You get an OQ validation report from Veeva with each update. However continuous configuration changes and Product qualification (PQ) are still the client’s responsibility and this is where OpKey comes into the picture.
“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 compliant solutions like Veeva CRM/ Veeva Vaults that helps life sciences and pharmaceutical companies in configuration validation. The secret sauce of OpKey’s success is incorporated with:
- Pre-built Validation Scripts
- Predictive Impact Analysis
- Configuration Validation Solution
OpKey provides Configuration Validation and Automated BCD generation with every configuration change. Also provided with Veeva Specific Record-and-playback engine that reads and interprets the documented test scripts to execute the test cases against the system in real-time. Furthermore, specific keywords for Veeva application enables testers to write even the most complex tests, in plaintext business readable domain-specific language using an extensive library of reusable actions.
With OpKey you can easily achieve better business outcomes, compliance, and complete End-to-End Configuration Validation solution. Gain a 100% data validation coverage for each configuration cycle and reduction in overall regression cycle time by over 50%.
Iffat Ara Khanam