The Problem: Pure Waterfall is Too Slow, Pure Agile Lacks GxP Rigor
Pure waterfall is too slow for modern pharma IT — by the time requirements are frozen and development complete, business needs have shifted. Pure agile lacks the documentation rigor and phase-gate controls that GxP demands. Most pharma organizations oscillate between the two, satisfying neither their delivery timelines nor their quality teams.
The Solution: Structured Agile Within a Governance Framework
The answer is a hybrid approach: agile execution within a structured governance framework that satisfies regulatory requirements. Development 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 Approach: Sprint-Aligned Validation
- Sprint-aligned validation: User story acceptance criteria map directly to test cases
- Continuous documentation: Validation artifacts updated each sprint, not batched post-development
- Quality gates: Formal checkpoints at phase boundaries with defined entry/exit criteria
- Risk-based testing: Effort proportional to GxP impact and system complexity
How ANG Associates Can Help
ANG Associates specializes in designing and implementing hybrid delivery methodologies for pharma IT. We train teams in GxP-adapted agile practices, establish quality gate frameworks, and provide project managers who are fluent in both agile ceremonies and validation lifecycle management. Our approach has been proven across multiple pharma clients — delivering faster while maintaining full regulatory compliance.