---
title: "When during the product lifecycle should change controls be implemented? Are they required for prototypes, version updates, or patch releases?"
description: "Change controls should be implemented whenever there is a proposed change to any aspect of a regulated product, process, or system that could impact its quality, safety, performance, or compliance."
category: "Frequently Asked Questions"
section: "Ketryx Lifecycle Management"
keywords: ["implemented", "product lifecycle", "patch", "controls", "updates", "releases", "required", "change"]
source_url: "https://support.ketryx.com/hc/en-us/articles/38158997098381-When-during-the-product-lifecycle-should-change-controls-be-implemented-Are-they-required-for-prototypes-version-updates-or-patch-releases"
last_reviewed: 2026-06-11
---

# When during the product lifecycle should change controls be implemented? Are they required for prototypes, version updates, or patch releases?

Change controls should be implemented whenever there is a **proposed change** to any aspect of a regulated product, process, or system that could impact its quality, safety, performance, or compliance. Therefore, change controls should be implemented **throughout the lifecycle** of the product **before a release/approval** of the product or a product submission.

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