Key takeaways
- Bring validation and quality colleagues into PI Planning as full participants.
- Plan regulatory evidence as backlog items with owners and acceptance criteria.
- Keep the gate model and the agile cadence, and connect them deliberately.
"Agile does not work here, we are regulated." It is one of the most common things we hear, and it is understandable. Validation, change control, procurement rules and audit trails all seem to pull against short planning cycles and fast feedback.
In practice, organisations under strict regulation can run Scaled Agile well. What they cannot do is copy a framework from a software company and expect it to fit. The controls have to be designed into the increment.
Start with who is in the room
PI Planning is where the next eight to twelve weeks of work are agreed. If quality assurance, validation and information security are not there, their requirements arrive later as surprises. Invite them as full participants with their own objectives, not as reviewers who sign off at the end.
Treat evidence as work
Validation plans, test evidence, risk assessments and change requests take real effort. When they are invisible on the board, teams overcommit. Write them as backlog items with owners, estimates and acceptance criteria. The board then shows the true cost of delivering a compliant change.
Compliance work that is not on the board is still work. It just becomes the reason the increment slips.
Connect gates and increments
Many regulated organisations already use a stage-gate lifecycle. That is not a problem for agile; it is an advantage. The gate decides whether an initiative should proceed and with what funding. The planning increment decides how the approved work is delivered. Make the link explicit:
- An initiative enters PI Planning only after it has passed the gate that releases delivery funding.
- Each increment produces the evidence the next gate will ask for.
- The go-live gate checks validation and operational readiness, not just working features.
Keep procurement in view
Supplier capacity is often the binding constraint. If a vendor team is part of the release train, include them in planning and agree their commitments in the same session. Where contracts are still being tendered, plan the dependency explicitly rather than hoping it lands in time.
Measure what matters
Track predictability (did we deliver what we committed to?), flow (how long does work take from start to finish?) and quality (how much rework did validation find?). These tell leaders far more than velocity figures.
Forlanto facilitates PI Planning, coaches teams through their first increments and designs the link between your governance and your delivery cadence. We are SAFe 6.0 certified and have run agile at scale in both commercial and regulated settings.
