Quality Management for Radiation Oncology In-House Software Products.

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.