Introducing test automation in a GxP governed ecosystem: How Sii Poland used Tricentis Tosca to build a healthcare client’s new AI system

The client needed to introduce test automation at the early stages of the project to reduce costs and time spent on testing the solution. But the introduction of test automation is not so simple in a highly regulated GxP environment. The biotech company reached out to Sii for help because of its testing experience and expertise. Sii is the leading IT, engineering, and BPO professional service provider.

The first thing that needed to be addressed was the client’s extensive technology landscape and variety of systems that required integration. An automation solution should have:

• Both front and back-end testing capabilities
• The ability to increase automation speed and lower maintenance effort
• The ability to cover the management of sensitive test data
• An easy way to scale up testing and run testing in parallel across distributed infrastructures and virtual machines

Secondly, the solution should deliver robust end-to-end automated testing for validated products that comply to pharma regulations. This step requires developing a wide range of documents and procedures including defining user requirements (URS), associated risk assessments (SRA, FRA), architecture, installation configuration, and verification. All of the mentioned deliverables must be compliant with internal operating procedures as well as overall industry standards.

During the planning phase, Sii assessed several test automation solutions including an enterprise testing tool and a custom opensource tool based on Robot Framework and Python. Sii’s architects supported this assessment and delivered a detailed solutions analysis and several technical proof of values to the client.

In the end, Sii selected Tricentis Tosca to cover the test automation of the biotech client’s program. Tosca satisfies all of the testing requirements and supports the versatile underlying technologies on an enterprise level with outstanding ROI.

Sii’s Poland location served as the Tosca implementation partner and supported the GxP compliance qualification process. To ensure that Tricentis Tosca was compliant with healthcare and pharma regulations, the Sii team of experts conducted these activities to validate the tool:

• System Risk Assessment – to calculate the overall risk level for the new solution
• User Requirement Specification – to set the scope of functionalities to be used by testers during User Acceptance Testing
• Design Specification – to document more technical features of Tosca
• Assurance Plan – to describe Test Plan and other activities needed for the qualification process
• System Operator Handbook and Technical Operating Procedure – created as an instruction for using the tool and the entire solution infrastructure
• Instructions for setup and configuration of Tosca server – included Common Multi-user Repository, License Server, and Tosca Agents
• Installation Verification scenarios – created to test all the components of the infrastructure
• Test scenarios – to test URS requirements
• User Acceptance Testing – conducted to validate the entire solution
• WebForms – to handle requests and incidents related to the Tosca solution
• gSite – created to be a ‘one-stop shop’ for all information related to Tosca for the client

After several months of implementation, detailed analysis, and document and process creations, Tricentis Tosca was successfully validated and allowed as a test automation solution to be used in the client’s projects.