Summary
Key results
Full takeover of QA for oncology-critical areas by Sii’s external team
Ability to run 50+ projects in parallel under a managed-service model without sacrificing quality
Complex oncology landscape and stringent regulations
As a global leader in oncology therapies and in-vitro diagnostics, the client develops and maintains a broad portfolio of IT systems spanning drug safety, regulatory processes, clinical trial operations, and scientific decision support. At this scale, every software change must be strictly controlled – for patient safety and for regulatory compliance.
The QA process was distributed across many teams and projects (Drug Safety, Registrations, Trial Execution, and Scientific Decision Support). The absence of a central approach to requirements capture, test planning, acceptance-test coordination, and automation created risks of delays, inconsistency, and excessive manual effort.
With the number of oncology systems and projects growing, the organization needed a partner to assume full QA responsibility, implement Computer System Validation (CSV) standards, and enforce regulated quality and good-practice frameworks (GxP, GAMP5). Given the clinical and data-integrity context, compliance with FDA 21 CFR Part 11 for electronic records and electronic signatures was also essential and had to be embedded in test strategy, documentation, and validation deliverables.
Managed QA service for oncology-critical systems
Sii Poland built a managed QA service accountable for providing and overseeing quality across key oncology domains. The goals were to standardize testing, assume end-to-end ownership of execution, and accelerate change delivery for systems supporting patient therapy.
Sii assembled a specialized team of testers, architects, and test managers experienced in CSV, GxP, GAMP5, and FDA 21 CFR Part 11, and deployed modern test-automation tooling. The collaboration model was a managed service with clear RACI, standardized metrics, and rapid onboarding of new projects.
Scope of work included:
- Standing up a QA team with deep CSV / GxP experience so test processes met pharmaceutical and regulatory expectations
- Mentoring and developing client-side test managers to strengthen internal capabilities and harmonize test governance
- Taking ownership of test planning and execution across drug safety, registrations, clinical trials, and scientific decision support – centralizing QA for oncology-critical systems
- Coordinating UAT and SAT with business stakeholders to formalize acceptance and reduce post-go-live risk
- Implementing Tricentis Tosca as the primary automation platform to improve regression coverage and speed releases
- Delivering automation with UFT, Selenium, Postman, RestAssured, Robot Framework, and Cypress across 40+ projects to reduce manual effort and accelerate validation
- Assuring quality of solutions – including Salesforce-based platforms analyzing therapeutic data for millions of patients – so clinical decision-support changes remained safe and compliant
- Ongoing advisory and process optimization to embed QA best practices, standardize quality metrics/reporting, and align validation assets with FDA 21 CFR Part 11 (audit trails, e-records/e-signatures), CSV, GxP, and GAMP5
With the managed-service model in place, Sii’s central QA team now governs planning, execution, and automation across dozens of concurrent projects. New initiatives can rapidly onboard to the standardized test process, and release decisions rely on consistent evidence and clear quality gates.
A scalable quality model serving millions of patients
By transferring QA to Sii Poland, the client gained a stable, scalable quality-assurance model that keeps pace with the growth of oncology therapies and supporting IT systems. Test automation and centralized governance accelerated changes in systems for clinical research, drug registrations, and therapy safety – shortening the time it takes to deliver innovation to patients.
The managed-service approach enables 50+ parallel projects without loss of control. The client can flex QA capacity, respond quickly to new business and regulatory demands, and benefit from Sii’s healthcare experience. Standardized testing – combined with automation and compliance with GxP, GAMP5, CSV, and FDA 21 CFR Part 11 – translates into higher software quality and greater trust in the systems that support treatment decisions for millions of patients worldwide.