Risk-based validation
The Objective
Implement a risk-based validation strategy for software development and deployment in a global SAP Programme.
The Challenge
Maintain high-quality standards in software development ensuring the reliability, accuracy and safety of systems used in GxP processes, while optimising the System Development Life Cycle to reduce cost and time without compromising compliance or quality.
The Solution
Using a risk-based approach, Integrity worked with the client leadership team and key vendors to develop an updated SDLC process, which included:
- Performing a risk assessment on the functional/user requirements to prioritise and determine the scope and rigor of verification testing (SIT, UAT and Regression Testing).
- Migration of paper-based requirement specifications into the Application Lifecycle Management (ALM) tool - optimising requirements, traceability and test reporting.
- Regression analysis of global template functionality enabled subsequent release test scope to be reduced to impacted RICEF objects and high-risk business processes.
- Reducing the number of formal milestone gates to prioritise key stakeholder resource. Programme consists of simultaneous multiple releases where each stream has its own set of project gates. High risk gates (Cutover, Go Live) completed with full global stakeholder list, other gates reduced to regional stakeholders (Start SIT, Start UAT, Start RT).
- Use of custom reporting within the SAP ChaRM tool to enable quicker deployment of code across project environments with reduced compliance approvals.
The Outcome
Multiple simultaneous SAP releases completed on time and to budget, with no significant issues identified post-go-live.
Deployment of standard global template with new regional requirements deployed in a compressed timeline.
Key Learnings
- Use a risk-based approach to prioritise areas for testing.
- Regression analysis used to reduce test scope for future releases.
- Streamlining the programme milestone gate process to prioritise key stakeholder resource.
- Use of custom reporting within the SAP ChaRM tool enabled quicker deployment of code across project environments.