# Quality Management for Radiation Oncology In-House Software Products

**Authors:** Sua Yoo, Phillip Antoine, Chunhao Wang, Yang Sheng, Q. Jackie Wu, Joseph Kowalski, Qiuwen Wu, Fang-Fang Yin, William Giles

PMC · DOI: 10.3390/bioengineering12040352 · Bioengineering · 2025-03-29

## TL;DR

This paper introduces a quality management program for in-house software used in radiation oncology to ensure consistent quality and safety in patient care.

## Contribution

The novel contribution is the development of a standardized in-house software quality management (ISQM) program for radiation oncology.

## Key findings

- The ISQM program includes quality assurance and comprehensive documentation for in-house software.
- The program was successfully implemented for existing software and will be used for future products.
- The ISQM framework ensures compliance and quality before clinical deployment.

## Abstract

(1) Objective: To develop and implement an in-house software quality management (ISQM) program to ensure the continuous, consistent quality of in-house software products. (2) Methods: The ISQM program consists of two key components: quality assurance (QA) and comprehensive documentation. The QA component involves code review, acceptance testing, commissioning, and routine quality checks. Documentation requirements encompass a product report, user manual, QA procedures and reports, release notes, version control, and logs. For each software product, the QA process must be completed, and all required documentation must be finalized before clinical deployment. (3) Results: The ISQM program was successfully developed and retrospectively implemented for existing software products. Future software products will adhere to the ISQM framework, ensuring compliance before clinical release. (4) Conclusions: This study demonstrates the successful development and implementation of the ISQM program—a standardized framework for managing the quality of in-house software products. The ISQM program ensures continuous and consistent oversight, playing a critical role in guaranteeing safe and high-quality patient care in the field of radiation oncology.

## Full-text entities

- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

2 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12025108/full.md

## References

16 references — full list in the complete paper: https://tomesphere.com/paper/PMC12025108/full.md

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Source: https://tomesphere.com/paper/PMC12025108