Healthcare & Bio-Tech Case Study
How Pie Medical Improved Compliance & DevOps Efficiency with SpiraPlan
Pie Medical Imaging replaced manual Office-based documentation with SpiraPlan to strengthen regulatory traceability and connect quality processes with DevOps workflows.
Pie Medical ImagingCustomer
Medical Device SoftwareIndustry
GlobalGeography
5Active Projects
The challenge
From manual documentation to integrated ALM
The R&D team needed a robust ALM solution that could improve regulatory adherence, automate compliance tracking, and fit securely into its development workflow.
- Manual documentation processes relied on Microsoft Office.
- Compliance tracking was not automated.
- DevOps workflows had limited integration with the quality-management process.
The Inflectra solution
Rapid SpiraPlan deployment with compliance built in
- SpiraPlan was deployed within days with minimal customization.
- The on-premise deployment supported security and compliance requirements.
- Robust APIs improved DevOps automation and CI/CD integration.
- Built-in auditability and reporting simplified regulatory adherence.
What changed
Inflectra provided a centralized, traceable working environment designed around the customer’s actual delivery and compliance needs.
- Requirements became more accessible.
- Documentation generation improved.
- The platform provided built-in risk management, strong traceability, and advanced QA capabilities.
Results & benefits
Measurable operational impact
25%
Increase in test coverage
20%
Improvement in risk management effectiveness
10%
Reduction in testing time
10%
Increase in deployment frequency
“SpiraPlan was very easy to set up and was usable almost from day one.”D. L., Functional Analyst, Pie Medical
What’s next
Pie Medical plans to expand API usage for deeper CI/CD integration, increase automation, and continue using SpiraPlan to support regulatory leadership.
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