Neither Pure Waterfall Nor Pure Agile
Pure waterfall is too slow for modern pharma IT. Pure agile lacks the documentation rigor and phase-gate controls that GxP demands. The answer for most pharma organizations is a hybrid approach: agile execution within a structured governance framework that satisfies regulatory requirements.
The Hybrid Model
Development work proceeds in sprints with iterative delivery, but key milestones — requirements baseline, design review, validation protocol approval, test summary report — follow a defined sequence with formal quality gates. The critical insight is that validation documentation can be produced iteratively alongside development, rather than as a monolithic post-development activity.
Implementation Patterns
- Sprint-aligned validation: user story acceptance criteria map directly to test cases
- Continuous documentation: validation artifacts updated each sprint, not batched
- Quality gates at phase boundaries with defined entry/exit criteria
- Risk-based testing: effort proportional to GxP impact and system complexity