Service
Systems Strategy & Governance
Put structure around how systems decisions are made, changes are executed, and processes evolve—built for regulated operations.
Systems
Governance
Recipe lifecycle
Release readiness
Problems we see
- Undefined ownership, decision rights, and escalation pathways
- Recipe and change execution friction across Manufacturing / QA / IT
- Inconsistent environments and release practices
- Validation effort disconnected from operational reality
What we deliver
- Governance model: roles, forums, RACI, decision criteria
- Recipe lifecycle and change control patterns
- Environment and release strategy (incl. readiness gates)
- Validation-aligned documentation approach (risk-based, practical)
- Cutover and sustainment alignment (support ownership + handoffs)
Success metrics (examples)
- Predictable change execution cadence
- Reduced rework during validation and approval cycles
- Clearer decision pathways and fewer stalled changes
- Improved release readiness and cutover confidence
Metrics depend on baseline maturity and scope. No guarantees—measurable progress with realistic constraints.
Engagement fit
- Sites running or implementing computerized systems needing stronger governance
- Scaling organizations transitioning from “project mode” to “operate mode”
- Teams preparing for upgrades or major release cycles
- Programs needing cross-functional alignment and execution discipline
Want a clear governance baseline in weeks, not months?
An Advisory Sprint can map decisions, roles, and a roadmap you can execute.