Yoo Sua, Antoine Phillip, Wang Chunhao, Sheng Yang, Wu Q Jackie, Kowalski Joseph, Wu Qiuwen, Yin Fang-Fang, Giles William
Department of Radiation Oncology, Duke University, Durham, NC 27701, USA.
Bioengineering (Basel). 2025 Mar 29;12(4):352. doi: 10.3390/bioengineering12040352.
(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.
(1) 目的:开发并实施内部软件质量管理(ISQM)程序,以确保内部软件产品的质量持续、一致。(2) 方法:ISQM程序由两个关键部分组成:质量保证(QA)和全面文档。QA部分包括代码审查、验收测试、调试和常规质量检查。文档要求涵盖产品报告、用户手册、QA程序和报告、发布说明、版本控制和日志。对于每个软件产品,在临床部署前必须完成QA流程,且所有所需文档必须定稿。(3) 结果:ISQM程序已成功开发,并对现有软件产品进行了回顾性实施。未来的软件产品将遵循ISQM框架,确保在临床发布前符合要求。(4) 结论:本研究证明了ISQM程序的成功开发和实施——这是一个用于管理内部软件产品质量的标准化框架。ISQM程序确保持续、一致的监督,在保证放射肿瘤学领域安全、高质量的患者护理方面发挥着关键作用。