In 30 seconds
- Agile and compliance can work together.
- Build compliance into the work, not after it.
- Automate evidence where possible.
Common concerns
- "Regulators expect full specifications up front"
- "Audits need documentation agile teams don't produce"
- "Frequent releases mean more risk"
Most can be addressed without abandoning agile.
Practical techniques
- Add compliance checks to the Definition of Done
- Keep traceability from requirement to test in your tools
- Automate evidence: test results, approvals, deployment logs
- Involve compliance experts in refinement
In regulated industries
Banks, healthcare and aerospace firms run agile under regulation. Small, well-tested changes with automated audit trails can be easier to justify than large, infrequent releases.
Myth vs reality
Myth · Regulation rules out agile.
Reality · Most regulations specify outcomes, not methods.
Myth · Compliance means heavy documentation.
Reality · It means sufficient evidence, often automatable.
Myth · Compliance is someone else's job.
Reality · Teams build it in with specialists' help.
FAQ
How do we handle formal sign-offs?
Build them into the pipeline as lightweight, timely approvals.
What about medical device rules?
Many medical device makers use agile with documented processes.
Do auditors accept agile?
Increasingly, especially with good traceability.