Quality Management for Radiation Oncology In-House Software Products

Area of Science:

• Medical Physics
• Radiation Oncology
• Software Engineering

Background:

• In-house software is increasingly used in radiation oncology.
• Ensuring the quality and consistency of this software is critical for patient safety.
• A standardized approach to managing software quality is needed.

Purpose of the Study:

• To develop and implement an in-house software quality management (ISQM) program.
• To ensure the continuous and consistent quality of in-house software products.
• To establish a framework for quality assurance and documentation in clinical software.

Main Methods:

• The ISQM program integrates quality assurance (QA) and comprehensive documentation.
• QA includes code review, acceptance testing, commissioning, and routine checks.
• Documentation includes product reports, user manuals, QA procedures, release notes, and logs.

Main Results:

• The ISQM program was successfully developed and implemented for existing software.
• Future software products will follow the ISQM framework for pre-clinical release compliance.
• The program establishes a standardized approach to software quality management.

Conclusions:

• The developed ISQM program provides a standardized framework for in-house software quality.
• This program ensures continuous oversight, contributing to safe and high-quality patient care in radiation oncology.
• The ISQM program is essential for maintaining software integrity in clinical settings.