Software Development Life Cycle (SDLC) is a structured framework for designing, building, testing, deploying, and maintaining software in a controlled, traceable way.
In regulated research environments, SDLC controls help ensure systems that handle clinical data are reliable, secure, and fit for intended use. SDLC practices typically include documented requirements, validation testing, change control, defect management, and release governance. When software supports regulated workflowsósuch as EDC, eTMF, or safety systemsóSDLC evidence can be reviewed during audits or inspections. Strong SDLC governance supports data integrity, cybersecurity, and operational continuity.