This client is a top five pharmaceuticals, consumer care, animal health, and medical care company driven to discover and manufacture innovative products that will improve human and animal health worldwide.
For a company operating in a highly regulated industry, compliance and risk are top-of mind considerations for any business process. This is particularly true for data and content migrations, where data error can result in unacceptable risks and adversely impact patient safety. Following an acquisition, the client was faced with completing a migration project from a legacy Clintrace system to Oracle Argus, which included the movement of more than one million safety data case records. To achieve success with the project, it was critical to harmonize safety data management with pharmacovigilance business processes, and to modernize related technology.
The client faced several early challenges. The first involved the differences between the Clintrace and Oracle Argus database structures themselves, which required complex migration transformations for more than 1,700 fields. Additionally, the more than one million case records needed to be migrated to the Argus system, which came with approximately 300 attributes per record. Finally, the deployment process included multiple applications with interdependencies for case handling, reporting, analysis and signal detection.
Due to strict regulatory oversight and concern for patient safety, there was little tolerance for migration error. These challenges created great complexity and potential costs, and given the criticality of the data, the client was extremely concerned about how to effectively test its migration efforts. The client was intrigued by the potential of Valiance’s automated migration testing and its claims of significant advantages over traditional testing techniques. Specifically, the client saw benefits in the ability to manage the complex source to destination transformation rules, the ability to verify 100% of the migrated data, cost savings, and increased compliance evidence.
Realizing the complexity of the migration at hand, as well as the challenges involved, the client recognized that it needed the help of a strategic partner to complete the project successfully. As a result, the QA/Validation team approached Valiance to execute a modest Proof of Concept (POC) to verify that its published claims for automated data migration testing could be realized on-site for the scope of this specific migration. After completing the POC successfully, Valiance was engaged to complete the migration testing and validation of all 1.2 million safety data management cases.
For this engagement, Valiance implemented its TRUcompare migration validation software. TRUcompare is a one-of-a-kind automated data and content migration testing software application that provides pre- and 100% post-migration testing. It generates objective evidence, particularly for compliance purposes, that the migration and all data transformations were completed in accordance with specifications. Using TRUcompare, the client was able to identify all data anomalies and resolve them before the production data migration occurred, a capability that was deemed essential with patient safety as a chief concern.
The Project Manager stated, “We were able to find all data anomalies, not just those identified from some samples during the rollout. This was absolutely imperative, as we are put our patients’ safety first. TRUcompare identified data errors that would have otherwise gone into the production system.”
Additionally, the client investigated the ROI of adopting Valiance’s approach and identified real savings. “Savings were earned several times by Valiance’s data migration testing process as the complexity of this migration prolonged the migration tool development. TRUcompare was reexecuted based on existing configurations where manual testing would have otherwise been required for every migration test run.”
Although the company’s prime objective was to migrate data without error, TRUcompare enabled the client to also save time, money and internal resources.
Understanding the risks associated with safety data migrations, the client took the initiative to collaborate with Valiance and confirm the advantages of automated testing through a brief Proof of Concept. Based on the success of the focused POC, Valiance and TRUcompare were selected to perform 100% testing on all 1.2 million records. The net result: Valiance, with TRUcompare and a unique approach to migrations, met each of the client’s expectations, ensuring the integrity of migrated case records while reducing the overall costs for the migration effort.