Summary
Key results
Regulatory compliance
Reliable results and shorter validation cycles
GxP requirements and limitations of manual testing
In the biotechnology industry, every IT system change is subject to strict GxP (Good x Practice) regulations that ensure the quality and integrity of data used in research and registration processes. Consequently, even test automation tools must undergo formal validation before being approved for use in a regulated environment.
Previously, testing processes for critical systems such as SAP, LIMS, and Salesforce were carried out manually, which required significant effort and extended the validation cycle. Moreover, the lack of automation limited the ability to implement changes quickly and increased the risk of non-compliance during audits.
The company needed a solution that would deliver repeatable, documented test results acceptable as regulatory evidence in registration processes. Sii was selected for its proven experience in regulated environments and a team of certified Tricentis Tosca experts.
Automated testing in a GxP-regulated environment
Sii Poland experts implemented Tricentis Tosca in full compliance with GxP requirements, covering both the technical and validation aspects. The project was carried out end-to-end – from tool selection to automation of tests in the regulated environment.
The scope of work included:
- analysis of the testing environment and recommendation of an automation tool meeting GxP requirements
- formal support in the procurement, licensing, and preparation of the Tosca environment
- installation and configuration of the solution in cooperation with the client’s IT and QA teams
- execution of a Proof of Concept (PoC) for test automation of SAP and LIMS systems
- support throughout the validation process of Tosca as a testing tool
Compliance, transparency, and reliability in testing processes
The implementation of Tricentis Tosca enabled full test automation in a GxP-regulated environment, ensuring compliance with international quality and audit standards. Thanks to process centralization and complete audit trails, QA teams can now track every test artifact end-to-end, gaining full visibility into all testing activities.
Test results are reported as part of Quarterly Business Reviews (QBR), supporting data-driven decision-making. Automation ensures consistent, reliable outcomes – free from false positives and negatives – delivering the same accuracy as manual testing in a fraction of the time.
Key results
- full compliance with GxP and audit requirements
- complete visibility into testing processes and artifacts
- stable, error-free test outcomes
- QA results integrated into QBR reports
- reduced validation time thanks to automation