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> Term

Deviation

Documented departure from an approved procedure, plan or expected result.

Detailed Explanation

Deviation is a core operational concept in medical & regulated software. Documented departure from an approved procedure, plan or expected result.

Why It Matters

Ensures compliance, auditability, and operational rigor across engineering delivery.

Common Failure Mode

Treating Deviation as superficial paperwork rather than an active engineering constraint.

Practical Example

Auditing Deviation evidence during a regulatory inspection or architecture review.

Production Manifestation

Formal engineering documentation, automated verification test suites, or regulated compliance sign-offs.

Frequently Asked Questions

What is Deviation in short?

Documented departure from an approved procedure, plan or expected result.

What is the most common failure mode?

Treating Deviation as superficial paperwork rather than an active engineering constraint.

AI Summary

Documented departure from an approved procedure, plan or expected result. Ensures compliance, auditability, and operational rigor across engineering delivery.