---
title: "Change Control Software for Life Sciences | Qualio"
canonical: "https://www.qualio.com/compliance-platform/change-control"
updatedDate: "2026-11-03T10:26:21.000Z"
description: "Change requests with the reason, the impact assessment and the linked documents, approved and signed. Built for ISO 13485, FDA QMSR and ICH Q10."
---

# Change Control Software for Life Sciences | Qualio

Change requests with the reason, the impact assessment and the linked documents, approved and signed. Built for ISO 13485, FDA QMSR and ICH Q10.

## Control every change

Each change is justified, assessed and signed off, and related documents can share one change request and go live together.

## Approved before anyone starts drafting

A change request goes to Quality approvers with its reason and impact assessment, and no document is touched until it is signed off.

## Change control that fits the change

Set up change control types, such as clerical or material, so a typo fix and a process change ask different questions.

## See the linked documents you might miss

Add documents to a change request and Qualio suggests the ones linked to them, so the work instruction that goes with the SOP is not left out.

## Related revisions go live together

Each document in the change request goes through its own approval, and closing the change request makes every included document effective at once, with each signature in the audit trail.

## Platform connections

### Copilot

It drafts the change control from the revised procedure, for the document owner to review and complete before approval.

### Compliance Frameworks

When a revision changes a procedure, Qualio reassesses the clauses it answers and flags any gap it opens, so the compliance impact shows up during the change.

### Document control and training

A change control that revises a procedure carries the new revision through review and approval, and the retraining goes out on the effective date the approver sets.

## Frequently Asked Questions

### What is change control in a QMS?

Change control is the procedure a regulated company uses to propose, assess, approve and document changes to its procedures, processes, systems and products, so nothing changes without a reason, an impact assessment and sign-off. ISO 13485, FDA QMSR and ICH Q10 all expect it. In Qualio, every document revision carries its own change control.

### Does Qualio support 21 CFR Part 11 for change control approvals?

Yes. Each approval is signed electronically with the signer's name, the date and time and the meaning of the signature shown on it, and every change to the change control is kept in its audit trail.

### What is the difference between change control and a change request?

A change request proposes a change and asks for approval to make it. Change control is the whole process around it, from assessment and approval to implementation and the history of what changed. In Qualio, a document change request groups several documents, each approved on its own, and each revision keeps its own change control.

### What should a change control impact assessment cover?

An impact assessment should cover which documents, processes, products, training and validated systems the change affects, any regulatory or product impact, and the risk of making or not making the change. In Qualio, every change request has an impact assessment, and Qualio suggests the documents linked to the ones you add so none are missed.

### How do you manage one change across several SOPs?

Group the affected documents into one change request, get it approved before drafting starts, revise each document through its normal review, and make them effective together so no SOP points to an outdated one. In Qualio, closing the change request can make every included revision effective at once.

### Is a clerical change treated differently from a material change?

Usually. Most procedures let clerical changes, such as typo or formatting fixes, follow a lighter path with no retraining, while material changes need a full impact assessment and approval. In Qualio you can set up a change control template for each type, and the author picks the right one when the draft starts.

## What did the last change touch that nobody checked?

Bring a change you have open and we will walk it through review, approval and the effective date in Qualio.