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The confluence of several factors, including: the growing recognition of the value of quantitative approaches to decision-making in drug development, advancements in numerical methods and analytics, and democratization of modern software engineering, has led to the emergence of multiple pharmacometrics-related software tools, both commercially and publicly licensed. A rigorously managed, high-quality, software development practice is central to reliable and reproducible scientific application and regulatory compliance for these tools. Professional software development best practices should typically be outlined in a Software Development Life Cycle (SDLC) policy or procedure, but the extent of guidance, consistency of methods, adherence to procedures, completeness of quality documentation, and execution rigor vary greatly across software development organizations or teams.

Adherence to quality software development standards is both critical and practical for commercial software developers and public open-source development teams alike. It is difficult, however, for consumers of various software tools to calibrate the extent to which quality systems have been embraced. To facilitate this endeavor, we propose an Open SDLC (OSDLC) guidance, which will be transparent, freely-accessible, informed by community feedback and vetted by real-world development teams. This presents a new option for software development teams serving the pharmacometrics discipline, allowing for transparent reflection of the quality systems and processes applied in their development efforts.

The following are key characteristics of software development activities supported by the proposed OSDLC:

• A growth mindset, acknowledging that the best answer may not be immediately evident and that failure is part of learning
• An openness to constructive feedback
• A commitment to maximizing the probability of success of a particular decision path, whether in agreement or not
• An eagerness to learn
• Efficient and transparent processes and documentation
• High quality deliverables
• Flexible implementation, emphasizing iterative development strategies

In the coming months, OSDLC content will be published via a public repository mechanism. We look forward to strong community engagement and participation.